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FDA 510(k)

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY

K-Number: K962910 · 1996-09-05

ApplicantUni-Patch, Inc.
Decision Date1996-09-05
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Patch, Inc.. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K962910. 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 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY?

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Uni-Patch, Inc.. The 510(k) number is K962910.

When did SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY receive FDA 510(k) clearance?

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962910.

Who is the listed applicant for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY?

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

What is the FDA product code for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY?

The FDA product code for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Uni-Patch, 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.

K983097TENS/FES/NMES ELECTRODESK962332TENS/FES/NMES ELECTRODESK961141EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220K925466CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLONK871222TANTONE MULTI-DAY #633 TENS ELECTRODE

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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