QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
FDA 510(k) clearance K973673 · decided 1997-11-20
Clearance details
- K-number
- K973673
- Device name
- QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
- Applicant
- Sunrise Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-26
- Decision date
- 1997-11-20
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Longmont, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sunrise Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. recall (Z-1019-2015) | Sunrise Medical (US) LLC | 2015-01-27 |
| Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT recall (Z-2113-2012) | Sunrise Medical (US) LLC | 2012-07-31 |
| Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing recall (Z-1103-2012) | Sunrise Medical (US) LLC | 2012-02-24 |
| Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manu recall (Z-0831-2011) | Sunrise Medical Inc | 2010-12-28 |