The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for 2004-oc Massage System, 2008-oc Massage System.
| Device ID | K122112 |
| 510k Number | K122112 |
| Device Name: | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | BIO COMPRESSION SYSTEMS, INC. 1983 Hazelwood Road Toms River, NJ 08754 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner BIO COMPRESSION SYSTEMS, INC. 1983 Hazelwood Road Toms River, NJ 08754 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311021236 | K122112 | 000 |