AXION USA LLC

FDA Device Registration & Listing · Carteret, NJ, US · Registration 3027329006

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
3027329006
FEI Number
3027329006
Entity Name
AXION USA LLC
City/State/Country
Carteret, NJ, US
Establishment Address
120 Raskulinecz Rd, Carteret, NJ 07008, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Axion USA (Owner Number: 10088047)
Owner / Operator Contact Address
1309 Coffeen Avenue STE 1200, Sheridan, WY 82801, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K213116
PMA Number
N/A

All Registered Proprietary Names

Axion Kinesiology Band Stim Pro axion Axion Stim-Pro Comfort Axion Stim-Pro I-2000

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2023-05-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2023-05-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-08-15
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2025-03-13

Official Correspondent

Marco Veser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axion USA
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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027329006. Last updated year: 2026. Please use registration number 3027329006 when referencing this establishment in official correspondence.
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