FDA UDI
In Commercial Distribution
🇺🇸 United States
ComfyHealth
DI: 04719879645606
·
Model: BP61
·
Comfy Health Group Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ComfyHealth
- Primary DI
- 04719879645606
- Version / Model
- BP61
- Company Name
- Comfy Health Group Co., Ltd.
- Labeler DUNS
- 658202517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 4
- Public Version Date
- 2025-07-09
- Public Version Status
- Update
- Public Device Record Key
- 60793044-b289-4253-8af7-e2f4c7671a9a
Device Description
BRACOO BP61 Low Back Airy Wrap Airy w/Cushion & Fixation GrayL-size
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43527 | Static magnetic orthopaedic orthosis | A body-support orthopaedic device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around a body area (e.g., shoulder, elbow, thoracic or lumbar spine region, knee, foot arch) and produce a weak magnetic flux field to assist the whole body’s innate healing capability to alleviate body aches and pains (e.g., from muscle soreness/stiffness, arthritis). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719879645606 | GS1 |