The following data is part of a premarket notification filed by Therapeutic Recreation Systems, Inc. with the FDA for The Sports Hand.
| Device ID | K821619 |
| 510k Number | K821619 |
| Device Name: | THE SPORTS HAND |
| Classification | Hand, External Limb Component, Mechanical |
| Applicant | THERAPEUTIC RECREATION SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRA |
| CFR Regulation Number | 890.3420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-02 |
| Decision Date | 1982-07-20 |