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FDA 510(k)

ANKLE WEIGHTS

K-Number: K823822 · 1983-01-14

ApplicantDanek Medical, Inc.
Decision Date1983-01-14
Product CodeIOD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANKLE WEIGHTS is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823822. The device is classified under product code IOD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANKLE WEIGHTS?

ANKLE WEIGHTS is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Danek Medical, Inc.. The 510(k) number is K823822.

When did ANKLE WEIGHTS receive FDA 510(k) clearance?

ANKLE WEIGHTS received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823822.

Who is the listed applicant for ANKLE WEIGHTS?

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

What is the FDA product code for ANKLE WEIGHTS?

The FDA product code for ANKLE WEIGHTS is IOD.

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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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