NEUROCONTROL FREEHAND SYSTEM(R)
FDA premarket approval P950035 · decided 1997-08-15
Approval details
- PMA number
- P950035
- Trade name
- NEUROCONTROL FREEHAND SYSTEM(R)
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 1995-10-31
- Decision date
- 1997-08-15
- Days to decision
- 654 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Cleveland, OH
- 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 injur
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 (K974475) | Biocontrol Technology, Inc. | 1998-03-02 |
| THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 (K960350) | Biocontrol Technology, Inc. | 1996-04-15 |