Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K211055 |
Device Name |
Microcurrent device (Model: HBR2-1) |
Applicant |
Shenzhen DJ Medical Equipment Co., Ltd. |
Room 801, Building A, FirstFlag Science & Technology Park, |
No. 26 Baili Road, Nanwan Street. |
Shenzhen,
CN
|
|
Applicant Contact |
Jet Li |
Correspondent |
Guangzhou KEDA biology technology co ltd |
6F, No.1 TianTai road, Science City, LuoGang District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2021 |
Decision Date | 11/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|