FDA Registration
Active
🇺🇸 United States
COMFORBACK INC
Reg #: 3024755175
·
FEI: 3024755175
·
Expires 2026
Products
4
Proprietary Names
11
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- COMFORBACK INC
- Registration Number
- 3024755175
- FEI Number
- 3024755175
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 77 Rowe St. Unit 046
- City
- Auburndale
- State
- MA
- ZIP
- 02466
- Country
- US
Owner / Operator
- Firm Name
- Comforback Inc
- Operator Number
- 10086284
- Address
- 405 Waltham St # 119
- City
- Lexington
- State
- MA
- Postal Code
- 02421
- Country
- US
- Correspondent
- Lingjun Zhu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2026-05-26 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2026-05-27 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2026-05-26 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2026-05-27 |
Proprietary Names
Night Support Wrist Brace
3-Strap Wrist Brace
Quick-Strap Wrist & Thumb Brace
Airmax Hinged Knee Brace
Post-Op Knee Brace GeniX ROM
Adjustable Hinged Knee Brace
Adjustable Cervical Collar Standard
Adjustable Cervical Collar Quick-Lock
Ankle Brace with Crossing Straps Fitgo
Lace-Up Ankle Stabilizer
Adjustable Ankle Stabilizer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility