K122112 is an FDA 510(k) clearance for the 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Bio Compression Systems, Inc. (Toms River, US). The FDA issued a Cleared decision on April 9, 2013, 266 days after receiving the submission on July 17, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K122112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2012 |
| Decision Date | April 09, 2013 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |