FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
K Number: K945676
·
Decision Jan 30, 1995
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
7
Review Days
73
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Basic Information
- Device Name
- GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
- K Number
- K945676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Selectivemed Components, Inc.
- Date Received
- November 18, 1994
- Decision Date
- January 30, 1995
- 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 Selectivemed Components, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | Feb 7, 2013 | Substantially Equivalent |
| K083756 | GUARDIAN 150 ELECTRODE | Jun 26, 2009 | Substantially Equivalent |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | May 20, 2003 | Substantially Equivalent |
| K020476 | MEDION 6000 | May 3, 2002 | Substantially Equivalent |
| K993081 | IO-DRIVE | Mar 3, 2000 | Substantially Equivalent |
| K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES | Dec 22, 1995 | Substantially Equivalent |