← Product Code [KNO](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNO) · K801709

# BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF (K801709)

_Fred Sammons, Inc. · KNO · Aug 7, 1980 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNO/K801709

## Device Facts

- **Applicant:** Fred Sammons, Inc.
- **Product Code:** [KNO](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNO.md)
- **Decision Date:** Aug 7, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3910
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNO/K801709](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNO/K801709)

**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
