FDA 510(k)

HEEL GARD

K-Number: K790954 · 1979-06-20

Decision Date1979-06-20

Product CodeFRK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HEEL GARD is the device name listed in this FDA 510(k) record. The listed applicant is Fem-Gard, Inc.. It received FDA 510(k) clearance on 1979-06-20 under 510(k) number K790954. The device is classified under product code FRK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEEL GARD?

HEEL GARD is a medical device that received FDA 510(k) clearance on 1979-06-20. The listed applicant is Fem-Gard, Inc.. The 510(k) number is K790954.

When did HEEL GARD receive FDA 510(k) clearance?

HEEL GARD received FDA 510(k) clearance on 1979-06-20, under 510(k) number K790954.

Who is the listed applicant for HEEL GARD?

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

What is the FDA product code for HEEL GARD?

The FDA product code for HEEL GARD is FRK.

Other records listing Fem-Gard, 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.

K790955COVER GARD

Related Devices (Code: FRK)

K896275JEDMED J-II CHAIRJedmed Instrument Co.K791016ULTICARE 2500 TREATMENT CHAIRAmerican Health Care Industries, Inc.K790955COVER GARDFem-Gard, Inc.

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.