The following data is part of a premarket notification filed by Cropper Medical, Inc. with the FDA for Synchro-link -contin-passive Motion Device/muscle.
| Device ID | K844995 |
| 510k Number | K844995 |
| Device Name: | SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE |
| Classification | Exerciser, Powered |
| Applicant | CROPPER MEDICAL, INC. 3007 N. 73RD. ST. SUITE D Scottsdale, AZ 85251 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-04-01 |