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FDA 510(k)

RELIEFBAND TENS UNIT (MODIFICATION)

K-Number: K961050 · 1997-08-01

ApplicantMaven Labs, Inc.
Decision Date1997-08-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RELIEFBAND TENS UNIT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Maven Labs, Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K961050. 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 RELIEFBAND TENS UNIT (MODIFICATION)?

RELIEFBAND TENS UNIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Maven Labs, Inc.. The 510(k) number is K961050.

When did RELIEFBAND TENS UNIT (MODIFICATION) receive FDA 510(k) clearance?

RELIEFBAND TENS UNIT (MODIFICATION) received FDA 510(k) clearance on 1997-08-01, under 510(k) number K961050.

Who is the listed applicant for RELIEFBAND TENS UNIT (MODIFICATION)?

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

What is the FDA product code for RELIEFBAND TENS UNIT (MODIFICATION)?

The FDA product code for RELIEFBAND TENS UNIT (MODIFICATION) is GZJ.

Related Clinical Trials

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.

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Other records listing Maven Labs, 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.

K901704RELIEF BAND (T.E.N.S. DEVICE)

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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