Cleared Traditional

PROTEAM CUSHION

K953352 · Iskra.Med · Physical Medicine

Nov 1995

Decision

135d

Days

Class 1

Risk

About This 510(k) Submission

K953352 is an FDA 510(k) clearance for the PROTEAM CUSHION, a Cushion, Flotation (Class I — General Controls, product code KIC), submitted by Iskra.Med (Great Neck,, US). The FDA issued a Cleared decision on November 29, 1995, 135 days after receiving the submission on July 17, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number	K953352 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 1995
Decision Date	November 29, 1995
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement