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510(k) Data Aggregation
K Number
K130691Device Name
ELECTROTHERAPY DEVICE (COMBO UNIT)
Manufacturer
Date Cleared
2013-12-20
(282 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:
- 1. Relaxation of muscle spasm.
- 2. Increase of local blood flow circulation
- 3. Prevention or retardation of disuse atrophy
- 4. Muscle re-education
- 5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.
Device Description
Electrotherapy Device (Combo Unit) Model 9612
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