Cleared Traditional

K790557 - CRUTCH
(FDA 510(k) Clearance)

K790557 · Maddak, Inc. · Physical Medicine device

Apr 1979

Decision

15d

Days

Class 1

Risk

K790557 is an FDA 510(k) clearance for the CRUTCH. This device is classified as a Crutch (Class I - General Controls, product code IPR).

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 15 days after receiving the submission on March 19, 1979.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3150.

Submission Details

510(k) Number	K790557 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 19, 1979
Decision Date	April 03, 1979
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—