The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Life-tech #1753 Biofeedback Trainer.
| Device ID | K812179 |
| 510k Number | K812179 |
| Device Name: | LIFE-TECH #1753 BIOFEEDBACK TRAINER |
| Classification | Device, Biofeedback |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-25 |