Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2432177

FEI Number

3012243493

Entity Name

FABRICATION ENT., INC.

City/State/Country

ELMSFORD, NY, US

Establishment Address

250 Clearbrook Road, STE 240, ELMSFORD, NY 10523, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FABRICATION ENT., INC. (Owner Number: 2432177)

Owner / Operator Contact Address

250 CLEARBROOK ROAD, SUITE 240, --, Elmsford, NY 10523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NeckPro FABRICATION ENTERP FABRICATON ENTERPRISES HOT PACK CanDo Relief Pak MULTIPLE CHAIRS TABLES FABRICATON ENTERPRIS MULTIPLE SCOOTER BOARDS MULTIPLE CHAIRS FABRICATION ENTERPRISES NON- Point Relief FabTrac Dipsters BASELINE GONIOMETER FabLife Baseline FABRICATION ENTERPRISES TUNING FORK RELIEF PAK VARIOUS NON-POWERED DYNAMOMETER Skillbuilders Relief Pak MULTIPLE PERCUSSOR PRODUCTS WARTENBERY PINWHEEL FABRICATION ENTERPRISES V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2022-04-04
GXB	Esthesiometer	Neurology	Class 1	882.1500	2002-03-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2002-03-06
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2024-11-15
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2016-12-05
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2002-04-24
BXL	Algesimeter, Manual	Anesthesiology	Class 1	868.1030	2002-03-06
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2002-04-24
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2002-04-24
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2002-03-06
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2016-12-08
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2022-02-01
FME	Gown, Examination	General Hospital	Class 1	880.6265	2016-12-05
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2002-03-06
IKW	Utensil, Homemaking	Physical Medicine	Class 1	890.5050	2018-09-17
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-06-16
HTH	Protractor	Orthopedic	Class 1	888.4600	2016-12-05
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2002-03-06
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	1992-07-13
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2002-03-06
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2016-05-05
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2016-12-05
GWZ	Percussor	Neurology	Class 1	882.1700	2002-03-06
GWY	Pinwheel	Neurology	Class 1	882.1750	2002-03-06
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2002-03-06

Official Correspondent

Andrew Goldberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FABRICATION ENT., INC.

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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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2183988	CORE PRODUCTS INTL., INC.	OSCEOLA, WI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2432177. Last updated year: 2026. Please use registration number 2432177 when referencing this establishment in official correspondence.