FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
K Number: K061166
·
Decision Aug 15, 2006
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
8
Review Days
110
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Basic Information
- Device Name
- DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
- K Number
- K061166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biowave Corporation
- Date Received
- April 27, 2006
- Decision Date
- August 15, 2006
- Product Code
- NHI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | FDA class 2 | Neurology |
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