FZF · Splint, Extremity, Inflatable, External
General, Plastic Surgery · 21 CFR 878.3900 · Class 1
Overview
| Product Code | FZF |
|---|---|
| Device Name | Splint, Extremity, Inflatable, External |
| Regulation | 21 CFR 878.3900 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881516 | COMPRESAID | R. Evans Corp. | Apr 29, 1988 | SESE |
| K874053 | INFLATABLE FULL ARM SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| K874052 | INFLATABLE HALF LEG SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| K874051 | INFLATABLE FULL LEG SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| K874050 | INFLATABLE FOOT & ANKLE SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| K853600 | INFLATABLE AIR SPLINTS | Hospitak, Inc. | Sep 19, 1985 | SESE |
| K831764 | URIAS PRESSURE SPLINTS, & FIRST AID | Svenol Andersen | Sep 12, 1983 | SESE |
Top Applicants
- Vinyl Technology, Inc. — 4 clearances
- Svenol Andersen — 1 clearance
- R. Evans Corp. — 1 clearance
- Hospitak, Inc. — 1 clearance
