← Product Code [IQI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI) · K926391

# ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391)

_Regulatory & Marketing Services, Inc. · IQI · Jul 22, 1993 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K926391

## Device Facts

- **Applicant:** Regulatory & Marketing Services, Inc.
- **Product Code:** [IQI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI.md)
- **Decision Date:** Jul 22, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3475
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K926391](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K926391)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com