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FDA 510(k)

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

K-Number: K163393 · 2017-08-04

ApplicantHi-Dow International, Inc.
Decision Date2017-08-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is a medical device manufactured by Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2017-08-04 under approval number K163393. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is a medical device that received FDA 510(k) clearance on 2017-08-04. It is manufactured by Hi-Dow International, Inc.. The 510(k) number is K163393.

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

Hi-Dow Wireless TENS/EMS System (Model HD-5N) received FDA 510(k) clearance on 2017-08-04, under approval number K163393.

What company makes Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is manufactured by Hi-Dow International, Inc..

What is the FDA product code for Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

The FDA product code for Hi-Dow Wireless TENS/EMS System (Model HD-5N) is NUH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Hi-Dow International, Inc.

K190617Wrap accessory electrodes K202337Pulsed electromagnetic field wrap K210383Wrap Accessory Electrodes K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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