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510(k) Data Aggregation
K Number
K020684Device Name
FINESUN EMS STIMULATOR
Manufacturer
Date Cleared
2002-05-23
(80 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
FINESUN WORLDWIDE INTL. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For model FS-004
- Relaxation of muscle spasms
For models FS-008, FS-012, FS-016 and FS-020
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Device Description
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