The following data is part of a premarket notification filed by J-tech, Inc. with the FDA for Gs-220 Hand Impairment Evaluation System.
| Device ID | K912526 |
| 510k Number | K912526 |
| Device Name: | GS-220 HAND IMPAIRMENT EVALUATION SYSTEM |
| Classification | Dynamometer, Ac-powered |
| Applicant | J-TECH, INC. 553 COBBLESTONE DR. Midvale, UT 84047 |
| Contact | Trach Livingston |
| Correspondent | Trach Livingston J-TECH, INC. 553 COBBLESTONE DR. Midvale, UT 84047 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-07 |
| Decision Date | 1991-09-05 |