FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K Number: K890747
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
60
Review Days
31
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Basic Information
- Device Name
- EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
- K Number
- K890747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Empi
- Date Received
- February 13, 1989
- Decision Date
- March 16, 1989
- 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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