Cleared Traditional

K760613 - FLOTATION UNIT, CHAIR (FDA 510(k) Clearance)

K760613 · Medpro, Inc. · Physical Medicine device

Oct 1976

Decision

34d

Days

Class 1

Risk

K760613 is an FDA 510(k) clearance for the FLOTATION UNIT, CHAIR. This device is classified as a Cushion, Flotation (Class I - General Controls, product code KIC).

Submitted by Medpro, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1976, 34 days after receiving the submission on September 10, 1976.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number	K760613 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 10, 1976
Decision Date	October 14, 1976
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—