The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for Mega Pulse Therapy Unit.
| Device ID | K841874 |
| 510k Number | K841874 |
| Device Name: | MEGA PULSE THERAPY UNIT |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | PHYSIO TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-05-31 |