FDA UDI
In Commercial Distribution
🇺🇸 United States
DR-HO'S
DI: 06970742221473
·
Model: PBR-1
·
Guangzhou Xinbo Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DR-HO'S
- Primary DI
- 06970742221473
- Version / Model
- PBR-1
- Company Name
- Guangzhou Xinbo Electronic Co., Ltd.
- Labeler DUNS
- 530683813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-01
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0fa1fead-1b0e-4815-9bfc-079f322fb3ad
Device Description
DR-HO's Perfect Back Rest This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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 |
|---|---|---|---|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41566 | Back-filling orthosis | A prefabricated (non-customized) externally applied and wearable device designed to fill in severe curvatures of the back. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970742221473 | GS1 |