FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H-WAVE
K Number: K112485
·
Decision Dec 6, 2011
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
1
Review Days
99
Basic Information
- Device Name
- H-WAVE
- K Number
- K112485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ELECTRONIC WAVEFORM LAB, INC.
- Date Received
- August 29, 2011
- Decision Date
- December 6, 2011
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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