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510(k) Data Aggregation
K Number
K130424Device Name
STIMEL-03
Manufacturer
Date Cleared
2013-07-11
(141 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
STIMEL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The STIMEL-03 is indicated for:
1. Relaxation of muscle spasms .
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Stroke Rehabilitation by muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
Device Description
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