The following data is part of a premarket notification filed by J-tech, Inc. with the FDA for Surface Electromyograph Biofeedback Muscle Activity Device.
| Device ID | K954737 |
| 510k Number | K954737 |
| Device Name: | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE |
| Classification | Device, Biofeedback |
| Applicant | J-TECH, INC. 50 WEST CANYON RD. Alpine, UT 84004 |
| Contact | Tracy Livingston |
| Correspondent | Tracy Livingston J-TECH, INC. 50 WEST CANYON RD. Alpine, UT 84004 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-07-03 |
| Summary: | summary |