Stimulator, Neuromuscular, Implanted
Basic Information
- Device Name
- Stimulator, Neuromuscular, Implanted
- Trade Name
- NEUROCONTROL FREEHAND SYSTEM(R)
- PMA Number
- P950035
- Device Class
- FDA Class 3
- Product Code
- GZC
- Generic Name
- Stimulator, neuromuscular, implanted
- Regulation Number
- 882.5860
- Medical Specialty
- Neurology
- Advisory Committee
- Physical Medicine
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 15, 1997
- Date Received
- October 31, 1995
- Expedited Review
- N
- Docket Number
- 97M-0458
Advisory Committee Statement
Approval for the Freehand System(R). The system includes: implantable receiver-stimulator Model 202-1, implantable epimysial electrode set Model 203-1, surgical electrode positioning kit Model 207-1, patient external system Model 204-1, programming system Model 209-1. The system is an upper extremity neuroprosthesis and is intended to improve a patient's ability to grasp, hold, and release objects. The system is indicated for use in patients who: are tetraplegic due to C5 or C6 spinal cord injury (ASIA Classification); have adequate functional range of motion of the upper extremity; have intact lower motor neuron innervation of hte forearm and hand musculature; and are skeletally mature.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZC | Stimulator, Neuromuscular, Implanted | FDA class 3 | Neurology |