| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | NEUROCONTROL FREEHAND SYSTEM(R) |
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| Generic Name | Stimulator, neuromuscular, implanted |
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| Regulation Number | 882.5860 |
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| Applicant | BIOCONTROL TECHNOLOGY, INC.
1945 EAST 97TH
CLEVELAND, OH 44106-4720 |
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| PMA Number | P950035 |
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| Date Received | 10/31/1995 |
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| Decision Date | 08/15/1997 |
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| Product Code |
GZC |
| Docket Number | 97M-0458 |
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| Notice Date | 11/14/1997 |
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| Advisory Committee |
Physical Medicine |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 |
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