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510(k) Data Aggregation
K Number
K981277Device Name
PERIFORM
Manufacturer
Date Cleared
1998-11-20
(226 days)
Product Code
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
VERIMED HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biofeedback/monitoring vaginal probe intended for:
- Treatment of stress, urge, and mixed incontinence.
- Facilitation in identification of the pubococcygeus muscles.
- Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.
Device Description
The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty. The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.
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