21 CFR 878.3900 — Splint, Extremity, Inflatable, External
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3900
Identification
An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.
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 § 878.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FZF | Splint, Extremity, Inflatable, External | 1 | 7 |
