Cruxi
FDA record research
The acquired FDA endpoint has no selected substantially-equivalent K-number decisions under primary product code QGH during 2021–2025. Its latest selected record across the endpoint is dated 2020-04-26. Use that dated record only as historical context. Check the recorded scope and current route separately; these data do not provide a recent timing benchmark. The complete-year window has 0 decisions; the separate all-observed-date count is 9. These denominators describe different date ranges.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.
Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 882.5940 Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a prescription device, including the pulse generator and its stimulation electrodes, used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head. (b) Classification. (1) Class II (special controls) when the device is intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The special controls for this device are: (i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized to ensure that the device performance characteristics are consistent with existing clinical performance data. (ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform. (iii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system. (v) Appropriate analysis/testing must validate electromagnetic compatibility. (vi) Appropriate software verification, validation, and hazard analysis must be performed. (vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes. (viii) The labeling for the device must include the following: (A) Information related to generic adverse events associated with electroconvulsive therapy device (ECT) treatment; (B) Instructions must contain the following specific recommendations to the user of the device: ( 1 ) Conduct of pre-ECT medical and psychiatric assessment (including pertinent medical and psychiatric history, physical examination, anesthesia assessment, dental assessment, and other studies as clinically appropriate); ( 2 ) Use of patient monitoring during the procedure; ( 3 ) Use of general anesthesia and neuromuscular blocking agents; ( 4 ) Use of mouth/dental protection during the procedure; ( 5 ) Use of EEG monitoring until seizure termination; ( 6 ) Instructions on electrode placement, including adequate skin preparation and use of conductive gel; and ( 7 ) Cognitive status monitoring prior to beginning ECT and during the course of treatment via formal neuropsychological assessment for evaluating specific cognitive functions ( e.g., orientation, attention, memory, executive function). (C) Clinical training needed by users of the device; (D) Information on the patient population in which the device is intended to be used; (E) Information on how the device operates and the typical course of treatment; (F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (G) A detailed summary of the device technical parameters; (H) Where appropriate, validated methods and instructions for reprocessing of any reusable components; (I) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems”; and (J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.” (ix) Patient labeling must be provided and include: (A) Relevant contraindications, warnings, precautions; (B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (C) Information on how the device operates and the typical course of treatment; (D) The potential benefits; (E) Alternative treatments; (F) The following statement, prominently placed: “Warning: ECT device use may be associated with: Disorientation, confusion, and memory problems”; (G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and (H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply: ( 1 ) ECT treatment may be associated with disorientation, confusion and memory loss, including short-term (anterograde) and long-term (autobiographical) memory loss following treatment. Based on the majority of clinical evidence, these side effects tend to go away within a few days to a few months after the last treatment with ECT. Although the incidence of permanent cognitive memory loss was not supported by the clinical literature, some patients have reported a permanent loss of memories of personal life events ( i.e., autobiographical memory); ( 2 ) Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for; and ( 3 ) The physical risks of ECT may include the following (in order of frequency of occurrence): ( i ) Pain/somatic discomfort (including headache, muscle soreness, and nausea); ( ii ) Skin burns; ( iii ) Physical trauma (including fractures, contusions, injury from falls, dental and oral injury); ( iv ) Prolonged or delayed onset seizures; ( v ) Pulmonary complications (hypoxemia, hypoventilation, aspiration, upper-airway obstruction); ( vi ) Cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and ( vii ) Death. (2) Classification: Class III (premarket approval) for the following intended uses: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in: (i) Patients under 13 years or (ii) Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 26, 2019, for any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 26, 2019, been found to be substantially equivalent to any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [83 FR 66123, Dec. 26, 2018]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.
There are 0 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.
9 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.
Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.
Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.
Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.
Separate partial-year update
0 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 0 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.
| Official record / device | Recorded applicant | Decision | Recorded type | Calendar days |
|---|---|---|---|---|
| K192834 ↗MECTA Sigma | Mecta Corporation | 2020-04-26 | Special | 207 |
| K965070 ↗SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | Mecta Corp. | 1997-03-06 | Traditional | 85 |
| K960754 ↗SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | Mecta Corp. | 1996-09-18 | Traditional | 208 |
| K945120 ↗THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Somatics, Inc. | 1995-10-26 | Traditional | 372 |
| K911144 ↗MF-500, MODIFICATION | Elcot, Inc. | 1991-10-18 | Traditional | 235 |
| K863815 ↗ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 | Elcot, Inc. | 1987-06-02 | Traditional | 245 |
| K860467 ↗ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | Medcraft Corp. | 1986-11-10 | Traditional | 277 |
| K852069 ↗MECTA ECT DEVICE MODELS SR & JR | Mecta Corp. | 1985-08-09 | Traditional | 91 |
Known context: US. Match the intended use and design with the recorded category before treating it as applicable.
| Source fact | Recorded value |
|---|---|
| FDA product code | QGH [1] |
| Generic device category | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder [1] |
| Recorded scope | Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. [1] |
| Recorded class | 2 [1] |
| Regulation | 882.5940 [1] |
| Medical specialty | Neurology [1] |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
No selected decision falls in the complete-year window. Any named records shown are separately dated historical or current-year research. Obtain their actual indications and assess the current route before using a comparator; the absence of a recent record does not establish an exemption or a route.
Useful evidence: Proposed indication/design, the dated named record if available, and a current route/comparator research rationale.
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
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