The following data is part of a premarket notification filed by Northern Orthopaedic Products, Inc. with the FDA for Hamex Two.
| Device ID | K951028 |
| 510k Number | K951028 |
| Device Name: | HAMEX TWO |
| Classification | Exerciser, Powered |
| Applicant | NORTHERN ORTHOPAEDIC PRODUCTS, INC. 54 WAKEFIELD ST. Hamden, CT 06517 |
| Contact | Thomas L Brady |
| Correspondent | Thomas L Brady NORTHERN ORTHOPAEDIC PRODUCTS, INC. 54 WAKEFIELD ST. Hamden, CT 06517 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-07 |
| Decision Date | 1995-12-11 |