The following data is part of a premarket notification filed by Orthopedic Development, Inc. with the FDA for Stretchpower.
| Device ID | K935188 |
| 510k Number | K935188 |
| Device Name: | STRETCHPOWER |
| Classification | Exerciser, Powered |
| Applicant | ORTHOPEDIC DEVELOPMENT, INC. 1700 SOUTH PARK ST., SUITE 201 Kalamazoo, MI 49001 |
| Contact | Alan A Halpern |
| Correspondent | Alan A Halpern ORTHOPEDIC DEVELOPMENT, INC. 1700 SOUTH PARK ST., SUITE 201 Kalamazoo, MI 49001 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1994-03-24 |