← Product Code [FYH](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYH) · K925145

# TRACE MODEL #'S 840, 841, 842, 845 (K925145)

_Trace Medical Equipment, Inc. · FYH · May 19, 1993 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/FYH/K925145

## Device Facts

- **Applicant:** Trace Medical Equipment, Inc.
- **Product Code:** [FYH](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FYH.md)
- **Decision Date:** May 19, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3910
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/FYH/K925145](https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/FYH/K925145)

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