FDA UDI
In Commercial Distribution
🇺🇸 United States
Quickie S-646
DI: 00016958044256
·
Model: S-646
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quickie S-646
- Primary DI
- 00016958044256
- Version / Model
- S-646
- Catalog Number
- EIS62
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-03
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 3af1ac85-7c9c-4467-9f6b-6d10feb57b4e
Device Description
The Quickie® S-6 Series electric wheelchairs are built tough for serious outdoor enthusiasts. Top speeds up to 8.5 mph, standard 4-pole motors, and dynamic suspension overcome tough terrain while the hybrid base maneuvers gracefully indoors. Seating options such as tilt, recline, and power elevating legrests ensure your positioning needs are met.
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
- 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 |
|---|---|---|---|---|
| 41875 | Electric-motor-driven wheelchair, occupant-controlled | An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958044256 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010917 | 000 |