The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 100, Cpm(power Excerise Equipment).
| Device ID | K851331 |
| 510k Number | K851331 |
| Device Name: | EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) |
| Classification | Exerciser, Powered |
| Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Contact | George E Mathiesen |
| Correspondent | George E Mathiesen EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-07-17 |