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FDA 510(k), K130802, OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
FDA 510(k), K130802, OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
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510(K) Number: K130802
Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 03/22/2013
Decision Date: 09/16/2013
Regulation Medical Specialty: Neurology
Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 03/22/2013
Decision Date: 09/16/2013
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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