510(k) K211055
K211055 is an FDA 510(k) premarket notification submitted by Shenzhen DJ Medical Equipment Co., Ltd. for the device "Microcurrent device (Model: HBR2-1)". The FDA issued a decision of Substantially Equivalent on Nov 5, 2021. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2021
- Date Received
- Apr 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)