510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080580Substantially Equivalent

Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small Dds275, Medium Ddm325, Large D

Axelgaard Mfg. Co., Ltd., Fallbrook CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080580 is the FDA 510(k) clearance record for COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D, a class II device, cleared for Axelgaard Mfg. Co., Ltd. on under FDA product code EGJ (Device, Iontophoresis, Other Uses). FDA records list 11 510(k) clearances for Axelgaard Mfg. Co., Ltd., from to . As of , FDA records show no recalls naming K080580.

Clearance record

Decision date
Received
(107 days to decision)
Product code
EGJ Device, Iontophoresis, Other Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Axelgaard Mfg. Co., Ltd. 520 Industrial Way, Fallbrook CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EGJ

Trailing 12 months

FDA records hold no clearances under product code EGJ in the trailing twelve months.

FDA records show no clearances under product code EGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260