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FDA 510(k)

ORTHOTRON MUSCLE STIMULATOR MK II DC

K-Number: K851037 · 1985-06-19

Decision Date1985-06-19
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

ORTHOTRON MUSCLE STIMULATOR MK II DC is the device name listed in this FDA 510(k) record. The listed applicant is Hodgkinson & Corby , Ltd.. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K851037. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ORTHOTRON MUSCLE STIMULATOR MK II DC?

ORTHOTRON MUSCLE STIMULATOR MK II DC is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Hodgkinson & Corby , Ltd.. The 510(k) number is K851037.

When did ORTHOTRON MUSCLE STIMULATOR MK II DC receive FDA 510(k) clearance?

ORTHOTRON MUSCLE STIMULATOR MK II DC received FDA 510(k) clearance on 1985-06-19, under 510(k) number K851037.

Who is the listed applicant for ORTHOTRON MUSCLE STIMULATOR MK II DC?

The FDA 510(k) record lists Hodgkinson & Corby , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOTRON MUSCLE STIMULATOR MK II DC?

The FDA product code for ORTHOTRON MUSCLE STIMULATOR MK II DC is IPF.

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.

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.

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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