# K253932: FACEGYM Pro Device (HD-109)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jul 23, 2026 after 226 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011935 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221443: PureLift Pro Plus, Xtreem Pulse, LLC (2022) Summary page 5.
- K250227: JOVS Electric Stimulation Beauty Device (JE2), Shenzhen Qianyu Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
The FACEGYM Pro Device (Model: HD-109) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K253932
Methodology: https://510kreport.com/methodology