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FDA 510(k)

MYOPAC (TM), MODEL 9600

K-Number: K864625 · 1986-12-29

ApplicantMedical Devices, Inc.
Decision Date1986-12-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

MYOPAC (TM), MODEL 9600 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1986-12-29 under 510(k) number K864625. 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 MYOPAC (TM), MODEL 9600?

MYOPAC (TM), MODEL 9600 is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Medical Devices, Inc.. The 510(k) number is K864625.

When did MYOPAC (TM), MODEL 9600 receive FDA 510(k) clearance?

MYOPAC (TM), MODEL 9600 received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864625.

Who is the listed applicant for MYOPAC (TM), MODEL 9600?

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

What is the FDA product code for MYOPAC (TM), MODEL 9600?

The FDA product code for MYOPAC (TM), MODEL 9600 is IPF.

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Other records listing Medical Devices, 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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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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