Wheelchair, Stair Climbing (IMK) — FDA decisions, comparisons and evidence
The 2021–2025 analysis contains 2 selected substantially-equivalent FDA decisions under primary product code IMK. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 0 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2025-01-30. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 2 decisions; the separate all-observed-date count is 3. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Recorded scope and its declared regulatory reference
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.
What scope does the FDA record describe?
A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 890.3890 Stair-climbing wheelchair. (a) Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. (b) Classification. Class II (special controls). The special controls for this device are: (1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use. (2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following: (i) Fatigue testing; (ii) Resistance to dynamic loads (impact testing); (iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure; (iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral); (v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and (vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions. (3) The skin-contacting components of the device must be demonstrated to be biocompatible. (4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended. (5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device. (6) Performance testing must demonstrate battery safety and evaluate longevity. (7) Performance testing must evaluate the flammability of device components. (8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following: (i) A clear description of the technological features of the device and the principles of how the device works; (ii) A clear description of the appropriate use environments/conditions, including prohibited environments; (iii) Preventive maintenance recommendations; (iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and (v) A detailed summary of the device-related adverse events and how to report any complications. (9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following: (i) Identification of patients who can effectively operate the device; and (ii) Instructions on how to fit, modify, or calibrate the device. (10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training. [79 FR 20782, Apr. 14, 2014]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
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.
3 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
2026 decisions through 2026-09-27
0 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 1 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
Latest decisions across the database
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.
Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.
A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. [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.
Which specific part of the recorded scope fits or differs?
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.
Have the cited section and its limitations been reviewed?
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.
Compare your intended use with a named decision
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
Explain the technology and evidence differences
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.
Prepare a scope-based schedule without a sparse timing benchmark
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.
Work packages and dependencies
Conditional: FDA 510(k) Submission Services — Review the supplied facts and evidence gaps before confirming the service scope.
Optional: Find FDA US Agent Services | Compare & Get Quotes — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
Optional: FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment) — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
What needs to happen first
FDA 510(k) Submission Services → Find FDA US Agent Services | Compare & Get Quotes: Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
FDA 510(k) Submission Services → FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment): Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
Questions for providers
Which of the named IMK decisions are actually comparable to our proposed indications and technology, and which would you exclude?
Which evidence differences prevent us from using the comparison yet, and what deliverable resolves each one?
Does your schedule separate submission preparation, testing, FDA interactions and customer response time? What assumptions change it?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
