BIO BOOST

Massager, Powered Inflatable Tube

BIO COMPRESSION SYSTEMS, INC.

The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Bio Boost.

Pre-market Notification Details

• Device ID: K961426
• 510k Number: K961426
• Device Name: BIO BOOST
• Classification: Massager, Powered Inflatable Tube
• Applicant: BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44147
• Contact: Daniel A Kracov
• Correspondent: Daniel A Kracov; BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44147
• Product Code: IRP
• CFR Regulation Number: 890.5650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-04-12
• Decision Date: 1996-10-28
• Summary: summary