FDA UDI
In Commercial Distribution
🇺🇸 United States
DR-HO'S
DI: 06970742221466
·
Model: Size A/B
·
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
- 06970742221466
- Version / Model
- Size A/B
- 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
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- c13a0cee-7b18-435e-81cb-2f46b564e6a4
Device Description
Decompression Belt This product is used for external fixation of the waist and longitudinal traction of the lumbar spine.It is composed by traction belt and air pump
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 |
|---|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | Orthopedic | 888.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61214 | Wearable lumbar spine traction device | An externally-worn orthopaedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. It consists of adjustable components worn superiorly under the rib cage, and inferiorly over the iliac crests, with rods holding the components apart that can be adjusted to apply traction forces by separation. It may include an additional attachable component intended for the treatment of scoliosis. It is intended for use in the home or a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970742221466 | GS1 |