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510(k) Data Aggregation
K Number
K210979Device Name
Prelivia
Manufacturer
Date Cleared
2021-05-13
(42 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Rehabtronics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Relaxation of muscle spasms; 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.
Device Description
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K Number
K153163Device Name
ReGrasp
Manufacturer
Date Cleared
2016-04-07
(157 days)
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
Rehabtronics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ReGrasp is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
- Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury.
Neuromuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of range of motion
- Prevention and/or reduction of disuse atrophy
- Increase of local blood circulation
- Reduction of muscle spasms
- Muscle re-education
Device Description
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