The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Theracushion Model 1000.
| Device ID | K861834 |
| 510k Number | K861834 |
| Device Name: | THERACUSHION MODEL 1000 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
| Contact | James M Biggins |
| Correspondent | James M Biggins 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 | 1986-05-13 |
| Decision Date | 1986-05-27 |