21 CFR 890.3475 — Sling, Arm, Overhead Supported
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3475
Identification
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ILE | Sling, Arm, Overhead Supported | 1 | 3 | |
| ILG | Stocking, Elastic | 1 | 8 | |
| ILH | Splint, Hand, And Components | 1 | 36 | |
| IOY | Support, Arm | 1 | 1 | |
| IQI | Orthosis, Limb Brace | 1 | 52 | |
| ITM | Cage, Knee | 1 | 5 | |
| ITQ | Joint, Knee, External Brace | 1 | 15 | |
| ITS | Joint, Hip, External Brace | 1 | 1 | |
| ITW | Joint, Ankle, External Brace | 1 | 1 | |
| KNP | Orthosis, Corrective Shoe | 1 | 7 | |
| LQX | Device, Finger-Sucking | 1 | 2 | |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | 1 | 2 | |
| OHI | Orthosis, Foot Drop | 1 | 1 | |
| PMV | Orthosis, Limb, For Back Pain | 1 | 1 | |
| QDT | Shoe With Adjustable Sole Units | 1 | 1 |
