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FDA 510(k)

TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL

K-Number: K914871 · 1991-12-18

ApplicantLabeltape Meditect, Inc.
Decision Date1991-12-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914871. 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 TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL?

TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K914871.

When did TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL receive FDA 510(k) clearance?

TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914871.

Who is the listed applicant for TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL?

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

What is the FDA product code for TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL?

The FDA product code for TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL is GZJ.

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Other records listing Labeltape Meditect, Inc. as applicant

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Related Devices (Code: GZJ)

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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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