FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
K Number: K850004
·
Decision Apr 2, 1985
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
6
Review Days
90
Basic Information
- Device Name
- TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
- K Number
- K850004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- TODD MEDICAL, INC.
- Date Received
- January 2, 1985
- Decision Date
- April 2, 1985
- 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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Other Clearances by TODD MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K873288 | CLOSED FOLEY CATHETER SYSTEM | Nov 27, 1987 | Unknown |
| K873499 | TODD MEDICAL/SKILLED CARE PRODUCTS | Nov 24, 1987 | Substantially Equivalent |
| K873287 | IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) | Nov 13, 1987 | Unknown |
| K873469 | TODD MEDICAL/SKILLED CARE PRODUCTS | Oct 29, 1987 | Substantially Equivalent |
| K850646 | ECLIPSE SELF ADHERING ELECTRODE | Sep 3, 1985 | Substantially Equivalent |