FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASTIM KIT
K Number: K013532
·
Decision Aug 22, 2002
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
11
Review Days
309
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Basic Information
- Device Name
- ULTRASTIM KIT
- K Number
- K013532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Axelgaard Mfg. Co., Ltd.
- Date Received
- October 17, 2001
- Decision Date
- August 22, 2002
- 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 Axelgaard Mfg. Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | Feb 13, 2014 | Substantially Equivalent |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | Jul 17, 2013 | Substantially Equivalent |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | Jun 18, 2008 | 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 |