The following data is part of a premarket notification filed by Medical Flotation Systems, Inc. with the FDA for Pneumatic Dorsiflexor.
| Device ID | K890200 |
| 510k Number | K890200 |
| Device Name: | PNEUMATIC DORSIFLEXOR |
| Classification | Exerciser, Powered |
| Applicant | MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
| Contact | Jacobs, Md |
| Correspondent | Jacobs, Md MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-02-03 |