The following data is part of a premarket notification filed by Medical Technology And Innovations, Inc. with the FDA for The Bledsoe Passive Motion Exerciser.
| Device ID | K854354 |
| 510k Number | K854354 |
| Device Name: | THE BLEDSOE PASSIVE MOTION EXERCISER |
| Classification | Exerciser, Powered |
| Applicant | MEDICAL TECHNOLOGY AND INNOVATIONS, INC. 2609 AERO DR. Grand Prairie, TX 75051 |
| Contact | Gary R Bledsoe |
| Correspondent | Gary R Bledsoe MEDICAL TECHNOLOGY AND INNOVATIONS, INC. 2609 AERO DR. Grand Prairie, TX 75051 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1986-02-06 |