QUICKIE & ZIPPIE SERIES
FDA 510(k) clearance K123975 · decided 2013-08-16
Clearance details
- K-number
- K123975
- Device name
- QUICKIE & ZIPPIE SERIES
- Applicant
- Sunrise Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-08-16
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fresno, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's recall (Z-2290-2016) | Sunrise Medical (US) LLC | 2016-07-25 |
| Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest recall (Z-2466-2015) | Sunrise Medical (US) LLC | 2015-08-26 |
| Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backre recall (Z-2467-2015) | Sunrise Medical (US) LLC | 2015-08-26 |
| Quickie Q7 Adult Rigid Wheelchair Model EIR4. recall (Z-1020-2015) | Sunrise Medical (US) LLC | 2015-01-27 |
| Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Mod recall (Z-0453-2014) | Sunrise Medical (US) LLC | 2013-12-05 |