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FDA 510(k)

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)

K-Number: K070299 · 2007-07-16

ApplicantEzfit Technology, Inc.
Decision Date2007-07-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) is the device name listed in this FDA 510(k) record. The listed applicant is Ezfit Technology, Inc.. It received FDA 510(k) clearance on 2007-07-16 under 510(k) number K070299. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)?

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) is a medical device that received FDA 510(k) clearance on 2007-07-16. The listed applicant is Ezfit Technology, Inc.. The 510(k) number is K070299.

When did EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) receive FDA 510(k) clearance?

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) received FDA 510(k) clearance on 2007-07-16, under 510(k) number K070299.

Who is the listed applicant for EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)?

The FDA 510(k) record lists Ezfit Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)?

The FDA product code for EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) is GZJ.

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

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

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