FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUICKIE & ZIPPIE SERIES
K Number: K123975
·
Decision Aug 16, 2013
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
14
Review Days
233
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Basic Information
- Device Name
- QUICKIE & ZIPPIE SERIES
- K Number
- K123975
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunrise Medical
- Date Received
- December 26, 2012
- Decision Date
- August 16, 2013
- Product Code
- IOR
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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ICON 35; ICON 45; ICON 60; ICON 30FAF
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FDA 510(k)
FDA Class 1
·Physical Medicine
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| K082209 | DEVILBISS DV5M SMARTLINK SYSTEM | Oct 28, 2008 | Substantially Equivalent |
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| K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | Sep 7, 2007 | Substantially Equivalent |
| K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS | Mar 17, 2006 | Substantially Equivalent |
| K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | Feb 3, 2006 | Substantially Equivalent |
| K043435 | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR | Feb 11, 2005 | Substantially Equivalent |
| K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES | Feb 11, 2005 | Substantially Equivalent |