FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
K Number: K901575
·
Decision May 2, 1990
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
19
Review Days
29
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Basic Information
- Device Name
- REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
- K Number
- K901575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Pioneering Technologies, Inc.
- Date Received
- April 3, 1990
- Decision Date
- May 2, 1990
- 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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| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | Jul 3, 1990 | Substantially Equivalent |
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| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | Apr 10, 1990 | Substantially Equivalent |
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