The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Demi-walker (regular).
| Device ID | K772268 |
| 510k Number | K772268 |
| Device Name: | DEMI-WALKER (REGULAR) |
| Classification | Joint, Knee, External Brace |
| Applicant | MEDFUSION SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITQ |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-09 |
| Decision Date | 1977-12-20 |