Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3900](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3900) → FZF — Splint, Extremity, Inflatable, External

# FZF · Splint, Extremity, Inflatable, External

_General, Plastic Surgery · 21 CFR 878.3900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF

## Overview

- **Product Code:** FZF
- **Device Name:** Splint, Extremity, Inflatable, External
- **Regulation:** [21 CFR 878.3900](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3900)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K881516.md) | COMPRESAID | R. Evans Corp. | Apr 29, 1988 | SESE |
| [K874053](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K874053.md) | INFLATABLE FULL ARM SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| [K874052](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K874052.md) | INFLATABLE HALF LEG SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| [K874051](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K874051.md) | INFLATABLE FULL LEG SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| [K874050](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K874050.md) | INFLATABLE FOOT & ANKLE SPLINT | Vinyl Technology, Inc. | Nov 23, 1987 | SESE |
| [K853600](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K853600.md) | INFLATABLE AIR SPLINTS | Hospitak, Inc. | Sep 19, 1985 | SESE |
| [K831764](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF/K831764.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZF)

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