QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES— 510(k) K973673
Substantially EquivalentSunrise Medical, Inc.
FDA 510(k) clearance K973673 for QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES, Substantially Equivalent on 1997-11-20. Applicant: Sunrise Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Sunrise Medical, Inc.
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Longmont, CO, US
Recent devices under product code IOR
view allMore clearances from Sunrise Medical, Inc.
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K973673
K-number listed on FDA's recall record- Z-1019-2015 — Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
- Z-2113-2012 — Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973673.
Data sourced from openFDA. This site is unofficial and independent of the FDA.