The following data is part of a premarket notification filed by J-tech, Inc. with the FDA for Large Muscle Strength Gauge.
| Device ID | K945630 |
| 510k Number | K945630 |
| Device Name: | LARGE MUSCLE STRENGTH GAUGE |
| Classification | Goniometer, Ac-powered |
| Applicant | J-TECH, INC. 324 WEST 1120 NORTH American Fork, UT 84003 |
| Contact | Tracy Livingston |
| Correspondent | Tracy Livingston J-TECH, INC. 324 WEST 1120 NORTH American Fork, UT 84003 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-16 |
| Decision Date | 1995-05-10 |