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FDA 510(k)

ANKLE FOOT ORTHOSIS

K-Number: K821639 · 1982-06-11

ApplicantFred Sammons, Inc.
Decision Date1982-06-11
Product CodeITW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANKLE FOOT ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1982-06-11 under 510(k) number K821639. The device is classified under product code ITW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANKLE FOOT ORTHOSIS?

ANKLE FOOT ORTHOSIS is a medical device that received FDA 510(k) clearance on 1982-06-11. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K821639.

When did ANKLE FOOT ORTHOSIS receive FDA 510(k) clearance?

ANKLE FOOT ORTHOSIS received FDA 510(k) clearance on 1982-06-11, under 510(k) number K821639.

Who is the listed applicant for ANKLE FOOT ORTHOSIS?

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

What is the FDA product code for ANKLE FOOT ORTHOSIS?

The FDA product code for ANKLE FOOT ORTHOSIS is ITW.

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Other records listing Fred Sammons, Inc. as applicant

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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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