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FDA 510(k)

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2

K-Number: K092448 · 2010-03-30

ApplicantHivox Biotek, Inc.
Decision Date2010-03-30
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K092448. 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 HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2?

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K092448.

When did HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 receive FDA 510(k) clearance?

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 received FDA 510(k) clearance on 2010-03-30, under 510(k) number K092448.

Who is the listed applicant for HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2?

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

What is the FDA product code for HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2?

The FDA product code for HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 is GZJ.

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Other records listing Hivox Biotek, 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.

K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)K242815POCKET TENS (EP-300)K232675Heating Tens, FT-615K223308HEATING TENS/EMS, FT-810RK221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2K211403HIVOX OTC Electrical Stimulator, FT610-B

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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

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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