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FDA 510(k)

MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS

K-Number: K925898 · 1993-01-28

ApplicantStaodyne, Inc.
Decision Date1993-01-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1993-01-28 under 510(k) number K925898. 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 MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS?

MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS is a medical device that received FDA 510(k) clearance on 1993-01-28. The listed applicant is Staodyne, Inc.. The 510(k) number is K925898.

When did MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS receive FDA 510(k) clearance?

MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS received FDA 510(k) clearance on 1993-01-28, under 510(k) number K925898.

Who is the listed applicant for MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS?

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

What is the FDA product code for MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS?

The FDA product code for MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS is GZJ.

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Other records listing Staodyne, Inc. as applicant

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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

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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