FDA UDI
In Commercial Distribution
🇺🇸 United States
Frontier V4
DI: 00016958059717
·
Model: Frontier V4 AWD or FWD
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Frontier V4
- Primary DI
- 00016958059717
- Version / Model
- Frontier V4 AWD or FWD
- Catalog Number
- EIMM
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-05
- Public Version
- 1
- Public Version Date
- 2023-09-13
- Public Version Status
- New
- Public Device Record Key
- 12edadf9-862d-41bb-b56d-96617c28ca3a
Device Description
The Magic Mobility Frontier V4 Front-Wheel Drive (FWD) offers a great solution to some of life's trickiest corners. The Frontier V4 FWD is designed for those wanting to get around their homes with ease, using desks and tables, or driving frequently.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57978 | Wheelchair recliner, battery-powered | A battery-powered mobile device designed to tilt (recline) a standard type wheelchair and occupant (not bariatric) to enable healthcare providers give treatment at a degree of tilt most efficient for them. The device includes a platform onto which the wheelchair/occupant is reversed and secured, and rechargeable batteries that drive an electric motor to power the tilting mechanism. It may include additional back- and headrest and may be moved on wheels for repositioning within a room or facility. It is used for treatments in dentistry, ophthalmology, maxillofacial and ear/nose/throat (ENT), podiatry (including diabetic foot care), physical therapy, and personal care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958059717 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213090 | 000 |