QUICKIE & ZIPPIE SERIES— 510(k) K123975
Substantially EquivalentSunrise Medical
FDA 510(k) clearance K123975 for QUICKIE & ZIPPIE SERIES, Substantially Equivalent on 2013-08-16. Applicant: Sunrise Medical. Device class: 1.
Clearance details
- Applicant
- Sunrise Medical
- 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
- Fresno, CA, US
Recent devices under product code IOR
view allMore clearances from Sunrise Medical
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 K123975
K-number listed on FDA's recall record- Z-2290-2016 — Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
- Z-2466-2015 — Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
- Z-2467-2015 — Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
- Z-1020-2015 — Quickie Q7 Adult Rigid Wheelchair Model EIR4.
- Z-0453-2014 — Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123975.
Data sourced from openFDA. This site is unofficial and independent of the FDA.