← Product Code [ILI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILI) · K823808

# VARIOUS ARM SLING (K823808)

_Danek Medical, Inc. · ILI · Jan 14, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILI/K823808

## Device Facts

- **Applicant:** Danek Medical, Inc.
- **Product Code:** [ILI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILI.md)
- **Decision Date:** Jan 14, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3640
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILI/K823808](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILI/K823808)

**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