Cleared Traditional

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS

K961425 · Bio Compression Systems, Inc. · Physical Medicine

Oct 1996

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K961425 is an FDA 510(k) clearance for the BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS, a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO), submitted by Bio Compression Systems, Inc. (Broadview Heights, US). The FDA issued a Cleared decision on October 28, 1996, 199 days after receiving the submission on April 12, 1996. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number	K961425 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 1996
Decision Date	October 28, 1996
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF