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FDA 510(k)

PMI TENS ELECTRODE

K-Number: K932849 · 1994-01-27

ApplicantPepin Mfg., Inc.
Decision Date1994-01-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PMI TENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Pepin Mfg., Inc.. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K932849. 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 PMI TENS ELECTRODE?

PMI TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Pepin Mfg., Inc.. The 510(k) number is K932849.

When did PMI TENS ELECTRODE receive FDA 510(k) clearance?

PMI TENS ELECTRODE received FDA 510(k) clearance on 1994-01-27, under 510(k) number K932849.

Who is the listed applicant for PMI TENS ELECTRODE?

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

What is the FDA product code for PMI TENS ELECTRODE?

The FDA product code for PMI TENS ELECTRODE 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 Pepin Mfg., 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.

K070807CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODESK060579COMFORT/IO IONTOPHORESIS ELECTRODES

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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