OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)— 510(k) K130802
Substantially EquivalentShenzhen Dongdixin Technology Co., Ltd.
FDA 510(k) clearance K130802 for OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060), Substantially Equivalent on 2013-09-16. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, Guangdong, CN
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