# K211055: Microcurrent device (Model: HBR2-1)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen DJ Medical Equipment Co., Ltd.
- Decided: Nov 5, 2021 after 210 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: 4 generations back to K011935 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173093: TAMA BEMS device, Tama Research Corporation (2018) Summary page 5.

## Indications for use
The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

Source page: https://510kreport.com/device/K211055
Methodology: https://510kreport.com/methodology