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FDA record research

Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) — FDA decisions, comparisons and evidence

The 2021–2025 analysis contains 84 selected substantially-equivalent FDA decisions under primary product code NUH. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 4 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-09-06. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 84 decisions; the separate all-observed-date count is 230. These denominators describe different date ranges.

Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.

Historical FDA comparison

2021–2025: five complete calendar years

Primary code NUH

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.

84Selected decisions in these five years
123.0Median receipt-to-decision calendar days
84Valid date pairs in the distribution

The middle 50% of the 84 valid date pairs spans 90.0–185.0 calendar days. This describes selected recorded submissions, including elapsed time outside active FDA review. It is not an FDA review-time measure or a delivery promise.

202114
202220
202315
202420
202515

Compare like submission types

Recorded typeDecisionsValid date pairsMedian calendar daysMiddle 50%
Abbreviated11Withheld: n < 20—
Special44Withheld: n < 20—
Traditional7979131.090.0–208.5

Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.

Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).

Filters, exclusions and reproducible calculation

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.

230 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

4 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 9 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.

Official record / deviceRecorded applicantDecisionRecorded typeCalendar days
K261131 ↗Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd2026-09-06Traditional153
K260412 ↗TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.2026-06-26Traditional137
K260425 ↗TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.2026-06-16Traditional126
K253896 ↗TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.2026-03-04Traditional89
K253305 ↗TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.2025-12-31Traditional93
K253740 ↗TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited2025-12-23Traditional29
K251958 ↗VEINOPLUS BackDynapulse Medical2025-12-23Traditional181
K252688 ↗Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd.2025-11-24Traditional90

Supporting documents actually acquired

Go beyond the database row

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.

The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.

Recorded classification context

Known context: US. Match the intended use and design with the recorded category before treating it as applicable.

Source factRecorded value
FDA product codeNUH [1]
Generic device categoryStimulator, Nerve, Transcutaneous, Over-The-Counter [1]
Recorded scopeTEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES [1]
Recorded class2 [1]
Regulation882.5890 [1]
Medical specialtyNeurology [1]

Build a comparison that explains the differences

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.

  1. 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.

  2. 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.

  3. Make the estimate comparable

    Use the 2021–2025 cohort, and compare the recorded submission type before discussing calendar elapsed time. Separate your own preparation work from the recorded receipt-to-decision period.

    Useful evidence: Chosen K numbers, submission types, dates and your own document/test readiness.

Work packages and dependencies

What needs to happen first

Questions for providers

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.

FDA openFDA — device classification records ↗

2026-10-05 · retrieved 2026-10-06

Audit details: precise locators and snapshot identifiers

Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5

  • [1] device-classification-0001-of-0001.json:results[396] · record 8f0373b629d97e73af582bfc786416b090887c5283d5a9e56cbd901cd4716d86

FDA 510(k) summary — K253896 ↗

Tue, 07 Apr 2026 11:21:11 GMT · retrieved 2026-10-06

Audit details: precise locators and snapshot identifiers

Source key D02 · snapshot 841abb2d50bf0518e7484b7cdcf9323947459d89c9f87dcd6dca782a4c3e2fd3

  • [2] PDF page 13 · record d450928b17d45bf715ae24ffedef87c71324add1f0f9742a184b126c2b00c003

FDA 510(k) summary — K251958 ↗

Thu, 08 Jan 2026 13:26:21 GMT · retrieved 2026-10-07

Audit details: precise locators and snapshot identifiers

Source key D02 · snapshot a5dcd4e3ad18345618bfd13c311b77ef70c1fb8b776bcccd6c1919e85b11656b

  • [4] PDF page 6 · record 4e8d33eddefd1505fbf087f188f58fd45297b052d973a9563dcef0c492c4e7a5

Prepare an editable project brief

Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.

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