← Product Code BWK · K840995

# ACUPUNCTURE INSOLES (K840995)

_Lu LU Enterprise Co. , Ltd. · BWK · Mar 27, 1984 · NE · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K840995

## Device Facts

- **Applicant:** Lu LU Enterprise Co. , Ltd.
- **Product Code:** BWK
- **Decision Date:** Mar 27, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** NE

---

**Source:** [https://fda.innolitics.com/device/K840995](https://fda.innolitics.com/device/K840995)

**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