The following data is part of a premarket notification filed by J-tech Medical, Inc. with the FDA for Jtech Commander And Algometer.
| Device ID | K971407 |
| 510k Number | K971407 |
| Device Name: | JTECH COMMANDER AND ALGOMETER |
| Classification | Dynamometer, Nonpowered |
| Applicant | J-TECH MEDICAL, INC. 357 WEST 910 SOUTH Heber City, UT 84032 |
| Contact | E. J Smith |
| Correspondent | E. J Smith J-TECH MEDICAL, INC. 357 WEST 910 SOUTH Heber City, UT 84032 |
| Product Code | HRW |
| CFR Regulation Number | 888.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-16 |
| Decision Date | 1998-04-20 |