The following data is part of a premarket notification filed by Shenzhen Dj Medical Equipment Co., Ltd. with the FDA for Microcurrent Device (model: Hbr2-1).
| Device ID | K211055 |
| 510k Number | K211055 |
| Device Name: | Microcurrent Device (Model: HBR2-1) |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Shenzhen DJ Medical Equipment Co., Ltd. Room 801, Building A, FirstFlag Science & Technology Park, No. 26 Baili Road, Nanwan Street. Shenzhen, CN |
| Contact | Jet Li |
| Correspondent | Jet Li Guangzhou KEDA Biology Technology Co Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-09 |
| Decision Date | 2021-11-05 |