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510(k) Data Aggregation
K Number
K143268Device Name
TENS AND POWERED MUSCLE STIMULATOR
Manufacturer
SHENZHEN AS-TEC TECHNOLOGY CO., LTD
Date Cleared
2015-07-21
(250 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN AS-TEC TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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