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510(k) Data Aggregation
K Number
K980346Device Name
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
Manufacturer
Date Cleared
1998-04-28
(90 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL TECHNOLOGY SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1.Relaxation of muscle spasms;
2.prevention or retardation of disuse atrophy;
3.increasing local blood circulation;
4.muscle re-education;
5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.
Device Description
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