FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EM TENS WINDOW ELECTRODES
K Number: K864032
·
Decision Dec 22, 1986
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
23
Review Days
68
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Basic Information
- Device Name
- EM TENS WINDOW ELECTRODES
- K Number
- K864032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Electromed Intl., Ltd.
- Date Received
- October 15, 1986
- Decision Date
- December 22, 1986
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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