Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D
FDA 510(k) K080580 · Axelgaard Mfg. Co., Ltd.
510(k) numberK080580
Submission
- Device name
- Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D
- Applicant
- Axelgaard Mfg. Co., Ltd.
Fallbrook, CA, US - Received
- March 3, 2008
- Decision date
- June 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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Questions and answers
When was Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D cleared by the FDA?
Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D (K080580) received a 510(k) decision of Substantially Equivalent on June 18, 2008, 107 days after the submission was received.
What is the product code of K080580?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.