510(k) K961426
K961426 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "BIO BOOST". The FDA issued a decision of Substantially Equivalent on October 28, 1996. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1996
- Date Received
- April 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type