FDA UDI
In Commercial Distribution
🇺🇸 United States
DR-HO'S
DI: 06970742221503
·
Model: AWC-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
- 06970742221503
- Version / Model
- AWC-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
- 1
- Public Version Date
- 2020-03-09
- Public Version Status
- New
- Public Device Record Key
- cde067bd-8918-4e6a-82c2-b9e516a836b7
Device Description
Air Wave Cushion This product is suitable for people who sit for a long time to relieve the fatigue caused by sitting for a long time. It's compose by cushion, cushion sleeves.The product is mainly formed through blister molding, forming a number of air bags arranged, the pressure technology between the air bags can effectively balance the pressure, to ensure that each air bag receives the same pressure, through other flow to massage the hip, relieve the fatigue caused by sitting for a long time.
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 |
|---|---|---|---|---|
| IPM | Cover, Limb | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44361 | Foam-filled chair cushion | A foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970742221503 | GS1 |