(157 days)
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
Not Found
This is a 510(k) clearance letter for the ReGrasp device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on specific performance criteria derived from a clinical study as would be seen for a PMA.
Therefore, I cannot provide the requested information from the given document.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).