The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Theracushion.
| Device ID | K853710 |
| 510k Number | K853710 |
| Device Name: | THERACUSHION |
| Classification | Massager, Therapeutic, Electric |
| Applicant | GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
| Contact | Thomas P Muchisky |
| Correspondent | Thomas P Muchisky GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1986-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THERACUSHION 87250865 5303349 Live/Registered |
Intuitive Enterprise LLC 2016-11-29 |