The following data is part of a premarket notification filed by Health Tronics Surgical Services, Inc. with the FDA for Healthtronic Omega Trac.
| Device ID | K881902 |
| 510k Number | K881902 |
| Device Name: | HEALTHTRONIC OMEGA TRAC |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. 10619 FOLSOM BLVD. Rancho Cordova, CA 95670 |
| Contact | Anseeuw, Dc |
| Correspondent | Anseeuw, Dc HEALTH TRONICS SURGICAL SERVICES, INC. 10619 FOLSOM BLVD. Rancho Cordova, CA 95670 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-06 |
| Decision Date | 1988-06-22 |