Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008724689

FEI Number

3008724689

Entity Name

COMFORTLAND INTERNATIONAL, LLC

City/State/Country

Mebane, NC, US

Establishment Address

709 A O SMITH RD, Mebane, NC 27302, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Comfortland International, LLC (Owner Number: 10033938)

Owner / Operator Contact Address

709 A O SMITH RD, Mebane, NC 27302, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMFORTMAX CERVICAL HOMETRAC CV-100 Comfort Dorsal Night Splint Comfortland Hinged Knee Brace Universal Comfortland Hined Knee Brace Universal Hinged Wrapaound Knee Brace Comfortland Dynamic Knee Brace Comfortland OA Knee Brace Hinged Wraparound Knee Support Neoprene Hinged Knee Support COMFORTLAND HAND CAST(31-700) Comfortland Foot Drop Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2017-12-14
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2012-12-19
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2013-11-07
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2020-10-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2011-09-27
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2012-04-02
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2010-10-20
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-09-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-03-07

Official Correspondent

Lois Tsui

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Comfortland International, LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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2320961	HOLLISTER, INC.	Mount Juliet, TN, US
3015058854	JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.	Changzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008724689. Last updated year: 2026. Please use registration number 3008724689 when referencing this establishment in official correspondence.