Cleared Traditional

BIO BOOST

K961426 · Bio Compression Systems, Inc. · Physical Medicine
Oct 1996
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K961426 is an FDA 510(k) clearance for the BIO BOOST, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), 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 890.5650.

Submission Details

510(k) Number K961426 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

Device Classification

Product Code IRP — Massager, Powered Inflatable Tube
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5650

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