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510(k) Data Aggregation
K Number
K222201Device Name
Biological Feedback and Stimulation System
Manufacturer
Date Cleared
2022-10-21
(88 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Medlander Medical Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
As a powered muscle stimulator the Biological Feedback and Stimulation System is indicated for thefollowing conditions:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a biofeedback device the Biological Feedback and Stimulation Systemis indicated for thefollowing conditions:
- Biofeedback, relaxationand muscle re-education purposes
As a nonimplanted electrical continence device the Biological Feedback and Stimulation Systemisindicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
● Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
Device Description
This Biological Feedback and Stimulation System is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
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