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FDA 510(k)

MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR

K-Number: K962462 · 1996-09-23

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1996-09-23
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K962462. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR?

MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K962462.

When did MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR receive FDA 510(k) clearance?

MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR received FDA 510(k) clearance on 1996-09-23, under 510(k) number K962462.

Who is the listed applicant for MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR?

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

What is the FDA product code for MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR?

The FDA product code for MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR is IPF.

Related Clinical Trials

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Other records listing Smith and Nephew Donjoy, 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.

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Related Devices (Code: IPF)

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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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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