K211055 is an FDA 510(k) clearance for the Microcurrent device (Model: HBR2-1). This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Shenzhen DJ Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 5, 2021, 210 days after receiving the submission on April 9, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K211055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2021 |
| Decision Date | November 05, 2021 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |