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FDA 510(k)

EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR

K-Number: K974514 · 1998-02-06

ApplicantNeuromotion, Inc.
Decision Date1998-02-06
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Neuromotion, Inc.. It received FDA 510(k) clearance on 1998-02-06 under 510(k) number K974514. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR?

EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Neuromotion, Inc.. The 510(k) number is K974514.

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

EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR received FDA 510(k) clearance on 1998-02-06, under 510(k) number K974514.

Who is the listed applicant for EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR?

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

What is the FDA product code for EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR?

The FDA product code for EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR is GZI.

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Related Devices (Code: GZI)

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.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

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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