FDA Registration
Active
🇺🇸 United States
COMFORTLAND INTERNATIONAL, LLC
Reg #: 3008724689
·
FEI: 3008724689
·
Expires 2026
Products
13
Proprietary Names
15
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- COMFORTLAND INTERNATIONAL, LLC
- Registration Number
- 3008724689
- FEI Number
- 3008724689
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 709 A O SMITH RD
- City
- Mebane
- State
- NC
- ZIP
- 27302
- Country
- US
Owner / Operator
- Firm Name
- Comfortland International, LLC
- Operator Number
- 10033938
- Address
- 709 A O SMITH RD
- City
- Mebane
- State
- NC
- Postal Code
- 27302
- Country
- US
- Correspondent
- Lois Tsui
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2017-12-14 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2012-12-19 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2013-11-07 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2020-10-28 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2011-09-27 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2012-04-02 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2010-10-20 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-09-27 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2017-03-07 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2017-06-29 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2011-09-27 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2017-12-14 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2014-04-25 |
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
21-202-5 ABD Shoulder Pillow II W/Sling X-Large
21-202-3 ABD Shoulder Pillow II W/Sling Medium
21-202-4 ABD Shoulder Pillow II W/Sling Large
21-202-2 ABD Shoulder Pillow II W/Sling Small
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility