Cleared Traditional

ANKLE CALF EXERCISER PHLEBOPUMP

K952975 · Prevent Products, Inc. · Physical Medicine

Sep 1996

Decision

456d

Days

Class 1

Risk

About This 510(k) Submission

K952975 is an FDA 510(k) clearance for the ANKLE CALF EXERCISER PHLEBOPUMP, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Prevent Products, Inc. (W St Paul, US). The FDA issued a Cleared decision on September 25, 1996, 456 days after receiving the submission on June 27, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K952975 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 1995
Decision Date	September 25, 1996
Days to Decision	456 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF