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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 the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) 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. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K163393.

When did Hi-Dow Wireless TENS/EMS System (Model HD-5N) receive FDA 510(k) clearance?

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

Who is the listed applicant for Hi-Dow Wireless TENS/EMS System (Model HD-5N)?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hi-Dow International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K210383Wrap Accessory ElectrodesK202337Pulsed electromagnetic field wrapK190617Wrap accessory electrodes

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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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