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510(k) Data Aggregation
K Number
K062453Device Name
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
Manufacturer
Date Cleared
2007-04-17
(238 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
KINGLY STAR INTL. TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Device Description
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
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