The following data is part of a premarket notification filed by Computer Sports Medicine, Inc. with the FDA for Humac System.
| Device ID | K952090 |
| 510k Number | K952090 |
| Device Name: | HUMAC SYSTEM |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | COMPUTER SPORTS MEDICINE, INC. 135 BEAVER ST. Waltham, MA 02154 |
| Contact | Richard J Potash |
| Correspondent | Richard J Potash COMPUTER SPORTS MEDICINE, INC. 135 BEAVER ST. Waltham, MA 02154 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-12-11 |