FDA product code NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter
NUH is the FDA product code for stimulator, nerve, transcutaneous, over-the-counter. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 230 510(k) submissions under NUH, 74 in the last five years, from 120 different applicants. The average 510(k) review took 180 days (median 148); 140 days on average over the last three years.
Definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NUH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 17 | 158 |
| 2018 | 16 | 168 |
| 2019 | 19 | 215 |
| 2020 | 14 | 218 |
| 2021 | 14 | 244 |
| 2022 | 20 | 122 |
| 2023 | 15 | 135 |
| 2024 | 20 | 149 |
| 2025 | 15 | 144 |
| 2026 | 4 | 126 |
Compare with all 510(k) review times · Search every NUH clearance
Top NUH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Everyway Medical Instruments Co.,Ltd | 14 | 2025-11-21 |
| Hivox Biotek, Inc. | 11 | 2026-06-16 |
| Well-Life Healthcare Limited | 11 | 2024-10-18 |
| Shenzhen Kentro Medical Electronics Co., Ltd. | 9 | 2024-11-05 |
| Omron Healthcare, Inc. | 7 | 2019-09-07 |
115 more applicants have NUH clearances. See the full list in Caduvo.
Most recent NUH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261131 | Shenzhen Osto Medical Technology Co.,Ltd | 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.) | 2026-09-06 | 153 |
| K260412 | Shenzhen Dongdixin Technology Co., Ltd. | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | 2026-06-26 | 137 |
| K260425 | Hivox Biotek, Inc. | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | 2026-06-16 | 126 |
| K253896 | Globalcare Medical Technology Co., Ltd. | TENS/EMS device (GUSE01) | 2026-03-04 | 89 |
| K253305 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | 2025-12-31 | 93 |
Recalls for NUH devices
openFDA lists no recalls for product code NUH.
Frequently asked questions
What is FDA product code NUH?
NUH is the FDA product code for stimulator, nerve, transcutaneous, over-the-counter. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NUH?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUH?
Across 230 cleared submissions the average was 180 days from receipt to decision (median 148).
Which companies have the most NUH clearances?
Everyway Medical Instruments Co.,Ltd (14); Hivox Biotek, Inc. (11); Well-Life Healthcare Limited (11); Shenzhen Kentro Medical Electronics Co., Ltd. (9); Omron Healthcare, Inc. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code NUH
- Run a recall and safety report across every NUH manufacturer
- Watch product code NUH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times