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510(k) Data Aggregation
K Number
K083704Device Name
NUTRAC PELVATOR, MODEL PEL 200
Manufacturer
VERITY SCIENTIFIC LTD.
Date Cleared
2009-07-14
(211 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
VERITY SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 'NuTracTM Pelvator' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women
Device Description
The 'NuTrac™ Pelvator' Pelvic Muscle Trainer is a small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.
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