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510(k) Data Aggregation
K Number
K213788Device Name
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Manufacturer
Date Cleared
2022-05-06
(151 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Bohuikang Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg.
TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities.
EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Device Description
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