FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K Number: K080580
·
Decision Jun 18, 2008
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
11
Review Days
107
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Basic Information
- Device Name
- COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
- K Number
- K080580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axelgaard Mfg. Co., Ltd.
- Date Received
- March 3, 2008
- Decision Date
- June 18, 2008
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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Other Clearances by Axelgaard Mfg. Co., Ltd.
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|---|---|---|---|
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| K013532 | ULTRASTIM KIT | Aug 22, 2002 | Substantially Equivalent |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | Jun 16, 2000 | Substantially Equivalent |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | Apr 13, 2000 | Substantially Equivalent |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | Dec 18, 1998 | Substantially Equivalent |
| K970426 | VALUETRODE | May 9, 1997 | Substantially Equivalent |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | Jan 28, 1988 | Substantially Equivalent |
| K872976 | TENS PALS PLUS | Sep 22, 1987 | Substantially Equivalent |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | Jun 18, 1985 | Substantially Equivalent |