HR UNIT
Device Facts
| Record ID | K782148 |
|---|---|
| Device Name | HR UNIT |
| Applicant | Parke-Davis Co. |
| Product Code | IQP · Physical Medicine |
| Decision Date | Jan 8, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3025 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
