FDA UDI
In Commercial Distribution
🇺🇸 United States
Quickie Access
DI: 00016958059410
·
Model: Access
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quickie Access
- Primary DI
- 00016958059410
- Version / Model
- Access
- Catalog Number
- EIR14
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-04
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- e222b987-d7d8-4e6d-b102-78bf84d9a952
Device Description
The QUICKIE® ACCESS™ solves multiple seating challenges while allowing clients to self-propel, offering much appreciated independence. Its low seat-to-floor height allows access under tables and desks. It also allows the client to foot propel. If the client is using their hands to propel, the ACCESS tilt provides greater accessibility to the wheels while also promoting a stable and functional posture. Up to 25° of tilt and 50° of recline offers clinically effective pressure relief.
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 |
|---|---|---|---|---|
| IOR | Wheelchair, Mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41512 | Push-rim manual wheelchair, non-bariatric | A non-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 by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958059410 | GS1 |