The following data is part of a premarket notification filed by Comfortex, Inc. with the FDA for Suspender Orthopedic Suspension Device.
| Device ID | K860037 |
| 510k Number | K860037 |
| Device Name: | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | COMFORTEX, INC. 420 MAIN ST. Winona, MN 55987 |
| Contact | Donald M Salyards |
| Correspondent | Donald M Salyards COMFORTEX, INC. 420 MAIN ST. Winona, MN 55987 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-01-21 |