Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003079019

FEI Number

3003079019

Entity Name

KOBAYASHI AMERICA MANUFACTURING, LLC

City/State/Country

Dalton, GA, US

Establishment Address

245 KRAFT DR, Dalton, GA 30721, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

KOBAYASHI AMERICA MANUFACTURING, LLC (Owner Number: 10049550)

Owner / Operator Contact Address

245 KRAFT DRIVE, Dalton, GA 30721, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2018-04-26
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-06-17
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-10-13
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2017-11-03
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2019-09-04
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-10-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KOBAYASHI AMERICA MANUFACTURING, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002965034	HEFEI KOBAYASHI DAILY PRODUCTS CO., LTD.	HEFEI Anhui, CN
3031604327	Hefei Kobayashi Daily Products Co., LTD., Xiyou Road 4479 Facility	Hefei Anhui, CN
3002324535	KOBAYASHI PHARMACEUTICAL CO., LTD.	Chuo-ku Osaka, JP
3004201320	Kobayashi Pharmaceutical (China) Co.,Ltd.	Minhang District Shanghai, CN

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

Similar Registrations

Registration Number	Establishment Name	Location
3015069920	NINGBO GUANGBO MEDICAL TECHNOLOGY CO.,LTD	Ningbo Zhejiang, CN
3043149162	DONGGUAN NESS SPORTS TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3042148166	CAM THANH TOY COMPANY LIMITED	Vu Ban District Nam Dinh, VN
3011182985	Kunshan Topgel Industry Co., Ltd	Kunshan Jiangsu, CN
3030444262	ELEVATE BRANDS OPCO LLC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003079019. Last updated year: 2026. Please use registration number 3003079019 when referencing this establishment in official correspondence.