FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DYNATRON IBOX IONTOPHORESIS DEVICE
K Number: K043047
·
Decision Jan 7, 2005
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
24
Review Days
64
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Basic Information
- Device Name
- DYNATRON IBOX IONTOPHORESIS DEVICE
- K Number
- K043047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Dynatronics Corp.
- Date Received
- November 4, 2004
- Decision Date
- January 7, 2005
- 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 Dynatronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K132057 | DYNATRON PELTIER THERMOSTIM PROBE | Jan 24, 2014 | Substantially Equivalent |
| K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | Feb 9, 2012 | Substantially Equivalent |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | Jun 14, 2006 | Substantially Equivalent |
| K051680 | DYNATRON DX2 TRACTION UNIT | Oct 11, 2005 | Substantially Equivalent |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | Jul 25, 2005 | Substantially Equivalent |
| K040729 | SOLARIS D890 THERAPY PROBE | Jun 2, 2004 | Substantially Equivalent |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Oct 22, 2003 | Substantially Equivalent |
| K010948 | DYNATRON STS RX | May 15, 2001 | Substantially Equivalent |
| K010565 | DYNATRON STS | May 15, 2001 | Substantially Equivalent |
| K993919 | DYNATRON 900 | Jan 3, 2000 | Substantially Equivalent |