The following data is part of a premarket notification filed by U.s. Mfg. & Management, Inc. with the FDA for Controlled Passive Motion Machine.
| Device ID | K920860 |
| 510k Number | K920860 |
| Device Name: | CONTROLLED PASSIVE MOTION MACHINE |
| Classification | Exerciser, Powered |
| Applicant | U.S. MFG. & MANAGEMENT, INC. 100 FIFTH ST. SHELBY SQUARE SUITE ONE Bristol, TN 37620 |
| Contact | Rand Watson |
| Correspondent | Rand Watson U.S. MFG. & MANAGEMENT, INC. 100 FIFTH ST. SHELBY SQUARE SUITE ONE Bristol, TN 37620 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-04-02 |