The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Club Foot Cpm Machine.
| Device ID | K903851 |
| 510k Number | K903851 |
| Device Name: | CLUB FOOT CPM MACHINE |
| Classification | Exerciser, Powered |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-10-19 |