Product code NUH: 510(k) clearances and predicates

Product code NUH covers 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.). FDA lists 230 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

230 clearances on file under product code NUH. Counts by year:

Year	Clearances
2022	20
2023	15
2024	20
2025	15
2026 so far	4

Recent clearances

Newest NUH clearances in the FDA index, with applicant and decision date:

• 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.), applicant Shenzhen Osto Medical Technology Co.,Ltd, decided 2026-09-06. FDA record
• K260412, TENS 7000 Rechargeable 4 Channel (TENS 7000H), applicant Shenzhen Dongdixin Technology Co., Ltd., decided 2026-06-26. FDA record
• K260425, TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237), applicant Hivox Biotek, Inc., decided 2026-06-16. FDA record
• K253896, TENS/EMS device (GUSE01), applicant Globalcare Medical Technology Co., Ltd., decided 2026-03-04. FDA record
• K253305, TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034), applicant Shenzhen Jiantuo Electronics Co., Ltd., decided 2025-12-31. FDA record
• K251958, VEINOPLUS Back, applicant Dynapulse Medical, decided 2025-12-23. FDA record
• K253740, TENS&EMS (HZ9151B, HZ9151C, HZ9151D), applicant Hong Qiangxing (Shenzhen) Electronics Limited, decided 2025-12-23. FDA record
• K252688, Transcutaneous Electrical Nerve Stimulator (RJTENS-2), applicant Bozhou Rongjian Medical Appliance Co., Ltd., decided 2025-11-24. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include TENS 7000 Rechargeable 4 Channel (TENS 7000H), TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237). Watch new NUH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code NUH?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent NUH clearances include 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.).

How many 510(k) clearances use product code NUH?

230 at the time this page was generated, from openFDA records.

How do I find a predicate device under NUH?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new NUH clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.