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510(k) Data Aggregation
K Number
K182581Device Name
PlayMakar Sport Muscle Stimulator, Model PRO-500
Manufacturer
Date Cleared
2018-11-21
(63 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PlayMakar Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Mode P4)
Device Description
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