Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008364966

FEI Number

3008364966

Entity Name

AMERICAN MEDICAL PRODUCTS LLC

City/State/Country

Eatontown, NJ, US

Establishment Address

151 Industrial Way East, Eatontown, NJ 07724, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

American Medical Products LLC (Owner Number: 10032198)

Owner / Operator Contact Address

151 B Industrial Way East, Eatontown, NJ 07724, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal Binder Omega Warrior LSO Freedom LSO Fastrac 627 Fastrac LPR 2000 Comfort 627 Freedom TLSO Omega Hot Cold Pack Quicksilver Knee Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2010-04-19
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2017-10-09
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2010-04-19
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2010-04-19
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2017-10-09
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2017-10-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2013-08-12

Official Correspondent

Bill Michalski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Medical Products LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008364966. Last updated year: 2026. Please use registration number 3008364966 when referencing this establishment in official correspondence.