← Product Code [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI) · K253340

# Electric Wheelchair (AL-208S-063) (K253340)

_Zhongshan A&J Medical Equipment Co., Ltd. · ITI · Apr 3, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253340

## Device Facts

- **Applicant:** Zhongshan A&J Medical Equipment Co., Ltd.
- **Product Code:** [ITI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI.md)
- **Decision Date:** Apr 3, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3860
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253340](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253340)

**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
