The following data is part of a premarket notification filed by Cybex with the FDA for Cybex Back Testing And Rehabilitation System.
| Device ID | K881681 |
| 510k Number | K881681 |
| Device Name: | CYBEX BACK TESTING AND REHABILITATION SYSTEM |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 |
| Contact | William Sauer |
| Correspondent | William Sauer CYBEX 2100 SMITHTOWN AVE. P.O. BOX 9003 Ronkonkoma, NY 11779 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1990-04-25 |