Cleared Traditional

K945667 - MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
(FDA 510(k) Clearance)

K945667 · Micos Medical Systems · Physical Medicine

Feb 1995

Decision

96d

Days

Class 1

Risk

K945667 is an FDA 510(k) clearance for the MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION. This device is classified as a Cushion, Flotation (Class I — General Controls, product code KIC).

Submitted by Micos Medical Systems (Hickory Corners, US). The FDA issued a Cleared decision on February 21, 1995, 96 days after receiving the submission on November 17, 1994.

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

Submission Details

510(k) Number	K945667 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1994
Decision Date	February 21, 1995
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement