AXELGAARD MFG. CO., LTD.

FDA Device Registration & Listing · FALLBROOK, CA, US · Registration 2025066

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2025066
FEI Number
1000603528
Entity Name
AXELGAARD MFG. CO., LTD.
City/State/Country
FALLBROOK, CA, US
Establishment Address
520 INDUSTRIAL WAY, FALLBROOK, CA 92028, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Axelgaard Manufacturing Co. Ltd. (Owner Number: 9010494)
Owner / Operator Contact Address
520 INDUSTRIAL WAY, --, Fallbrook, CA 92028, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K000206
PMA Number
N/A

All Registered Proprietary Names

Buffered Iontophoresis Electrodes Comfort Iontophoresis Electrodes / UltraStim ELectrode, Model US4040 Little PALS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2008-10-09
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-16
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2008-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axelgaard Manufacturing Co. Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K842483 Santa Barbara Medco, Inc. SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC 1984-08-31
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025066. Last updated year: 2026. Please use registration number 2025066 when referencing this establishment in official correspondence.
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