The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isostation Shoulder Machine.
| Device ID | K841849 |
| 510k Number | K841849 |
| Device Name: | ISOSTATION SHOULDER MACHINE |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | ISOTECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-03 |
| Decision Date | 1984-05-14 |