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FDA 510(k)

TENS/EMS COMBO, EMS, TENS

K-Number: K082514 · 2008-10-21

ApplicantMedihightec Medical Co., Ltd.
Decision Date2008-10-21
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS/EMS COMBO, EMS, TENS is the device name listed in this FDA 510(k) record. The listed applicant is Medihightec Medical Co., Ltd.. It received FDA 510(k) clearance on 2008-10-21 under 510(k) number K082514. 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 TENS/EMS COMBO, EMS, TENS?

TENS/EMS COMBO, EMS, TENS is a medical device that received FDA 510(k) clearance on 2008-10-21. The listed applicant is Medihightec Medical Co., Ltd.. The 510(k) number is K082514.

When did TENS/EMS COMBO, EMS, TENS receive FDA 510(k) clearance?

TENS/EMS COMBO, EMS, TENS received FDA 510(k) clearance on 2008-10-21, under 510(k) number K082514.

Who is the listed applicant for TENS/EMS COMBO, EMS, TENS?

The FDA 510(k) record lists Medihightec Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS/EMS COMBO, EMS, TENS?

The FDA product code for TENS/EMS COMBO, EMS, TENS 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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