SPECIALIST(R) WALKER
Device Facts
| Record ID | K924984 |
|---|---|
| Device Name | SPECIALIST(R) WALKER |
| Applicant | Johnson & Johnson Orthopaedics, Inc. |
| Product Code | FYH · General, Plastic Surgery |
| Decision Date | Feb 1, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3910 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
