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FDA 510(k)

NEUROMUSCULAR STIMULATOR

K-Number: K932611 · 1994-01-31

ApplicantMyo/Kinetic Systems, Inc.
Decision Date1994-01-31
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMUSCULAR STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Myo/Kinetic Systems, Inc.. It received FDA 510(k) clearance on 1994-01-31 under 510(k) number K932611. 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 NEUROMUSCULAR STIMULATOR?

NEUROMUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Myo/Kinetic Systems, Inc.. The 510(k) number is K932611.

When did NEUROMUSCULAR STIMULATOR receive FDA 510(k) clearance?

NEUROMUSCULAR STIMULATOR received FDA 510(k) clearance on 1994-01-31, under 510(k) number K932611.

Who is the listed applicant for NEUROMUSCULAR STIMULATOR?

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

What is the FDA product code for NEUROMUSCULAR STIMULATOR?

The FDA product code for NEUROMUSCULAR STIMULATOR is GZJ.

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Other records listing Myo/Kinetic Systems, 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.

K945937TE-800 PELVIC FLOOR EXERCISERK945292TS-700P CONTROL XP ELECTRICAL STIMULATORK944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYK936041UROGRAM CYSTOMETROGRAMK932764THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)K932399THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)

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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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