Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Q: What is the product code of K163393?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K163393 · Hi-Dow International, Inc.

Substantially Equivalent

510(k) numberK163393

Submission

Device name: Hi-Dow Wireless TENS/EMS System (Model HD-5N)
Applicant: Hi-Dow International, Inc.
Maryland Heights, MO, US
Received: December 2, 2016
Decision date: August 4, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other 510(k)s with product code NUH

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K261131	Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional	Shenzhen Osto Medical Technology Co.,Ltd	09/06/2026SE
K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional	Shenzhen Dongdixin Technology Co., Ltd.	06/26/2026SE
K260425	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional	Hivox Biotek, Inc.	06/16/2026SE
K253896	TENS/EMS device (GUSE01)NUH · Traditional	Globalcare Medical Technology Co., Ltd.	03/04/2026SE
K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional	Shenzhen Jiantuo Electronics Co., Ltd.	12/31/2025SE
K253740	Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional	Hong Qiangxing (Shenzhen) Electronics Limited	12/23/2025SE
K251958	VEINOPLUS BackNUH · Traditional	Dynapulse Medical	12/23/2025SE
K252688	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	11/24/2025SE
K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special	Everyway Medical Instruments Co.,Ltd	11/21/2025SE
K243131	Triathlon ProNUH · Traditional	Sigma Biomedical	11/07/2025SE

More from Sigma Biomedical

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K190617	Wrap accessory electrodesGXY · Traditional	07/02/2019SE
K102598	Hi-Dow-XpNUH · Traditional	05/13/2011SE

Questions and answers

When was Hi-Dow Wireless TENS/EMS System (Model HD-5N) cleared by the FDA?

Hi-Dow Wireless TENS/EMS System (Model HD-5N) (K163393) received a 510(k) decision of Substantially Equivalent on August 4, 2017, 245 days after the submission was received.

What is the product code of K163393?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.