Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2415591

FEI Number

2415591

Entity Name

Nortech Laboratories, Inc.

City/State/Country

E Farmingdale, NY, US

Establishment Address

125 Sherwood Ave, E Farmingdale, NY 11735, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

NORTECH LABORATORIES (Owner Number: 2415591)

Owner / Operator Contact Address

125 SHERWOOD AVE, --, Farmingdale, NY 11735, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InstaKool Instant Cold Pack InstaHeet Instant Hot Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2004-12-02

Official Correspondent

CARYN NAZARIEH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORTECH LABORATORIES

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2415591. Last updated year: 2026. Please use registration number 2415591 when referencing this establishment in official correspondence.