The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small Dds275, Medium Ddm325, Large D.
| Device ID | K080580 |
| 510k Number | K080580 |
| Device Name: | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY Fallbrook, CA 92028 -2244 |
| Contact | Dan P Jeffery |
| Correspondent | Dan P Jeffery AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY Fallbrook, CA 92028 -2244 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815991022081 | K080580 | 000 |
| 10885914070717 | K080580 | 000 |
| 10885914070724 | K080580 | 000 |
| 10885914070779 | K080580 | 000 |
| 00856817005888 | K080580 | 000 |
| 00856817005895 | K080580 | 000 |
| 00856817005901 | K080580 | 000 |
| 00856817005918 | K080580 | 000 |
| 00815991022050 | K080580 | 000 |
| 00815991022067 | K080580 | 000 |
| 00815991022074 | K080580 | 000 |
| 10885914070700 | K080580 | 000 |