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510(k) Data Aggregation
K Number
K080950Device Name
STIWELL MED4
Manufacturer
OTTO BOCK, AUSTRIA GMBH
Date Cleared
2009-04-02
(364 days)
Product Code
IPF, GZI, GZJ, HCC, KPI
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
OTTO BOCK, AUSTRIA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following 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 transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated 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 detruser 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
The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.
The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.
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