FDA UDI
In Commercial Distribution
🇺🇸 United States
Hi-Fortune
DI: 06973852590040
·
Model: HM03MS
·
Kunshan Hi-Fortune Health Products Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hi-Fortune
- Primary DI
- 06973852590040
- Version / Model
- HM03MS
- Company Name
- Kunshan Hi-Fortune Health Products Co.,Ltd
- Labeler DUNS
- 548310008
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-23
- Public Version
- 1
- Public Version Date
- 2021-11-01
- Public Version Status
- New
- Public Device Record Key
- 82ff87cc-a10d-4314-b0a0-1ac0ce3c9777
Device Description
Weight: 10.5kg, L745mm*W325mm*H760mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IMN | Climber, Curb, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58086 | All-plastic conventional wheelchair | An all-plastic wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (non-bariatric) and designed to be manually propelled by the occupant while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. It contains no metal parts and may be safely used in magnetic resonance imaging (MRI) environments and security scanners, submersed in water (e.g., swimming pool, balneotherapy), and used in a shower. The device cannot be folded or readily dismantled for transport. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973852590040 | GS1 |