FDA UDI
In Commercial Distribution
🇺🇸 United States
Xtreme X8 4WD
DI: 00016958059694
·
Model: Xtreme X8
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xtreme X8 4WD
- Primary DI
- 00016958059694
- Version / Model
- Xtreme X8
- 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
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- b348f742-e809-4131-978a-0a64fe3888d2
Device Description
Through sand or snow and up or down curbs, the Extreme X8 is a true all-terrain power wheelchair. Unrivaled 4x4 off-road performance and reliability make it the perfect outdoor wheelchair for adventurers, explorers, and rural workers alike.
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 | 00016958059694 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211574 | 000 |