FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K Number: K031289
·
Decision May 9, 2003
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
19
Review Days
16
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Basic Information
- Device Name
- QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
- K Number
- K031289
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunrise Medical, Inc.
- Date Received
- April 23, 2003
- Decision Date
- May 9, 2003
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Sunrise Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | Sep 10, 2007 | Substantially Equivalent |
| K062701 | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR | Sep 25, 2006 | Substantially Equivalent |
| K010917 | POWER TILT AND RECLINE SYSTEM | May 15, 2001 | Substantially Equivalent |
| K011268 | BREEZY WHEELCHAIR, MODEL 300 | May 15, 2001 | Substantially Equivalent |
| K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | Dec 15, 2000 | Substantially Equivalent |
| K981885 | SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE | Nov 12, 1998 | Substantially Equivalent |
| K983677 | QUICKIE G SERIES, MODEL G-424 | Nov 6, 1998 | Substantially Equivalent |
| K983520 | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD | Nov 6, 1998 | Substantially Equivalent |
| K981462 | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 | Nov 6, 1998 | Substantially Equivalent |
| K983639 | ZIPPIE GS, MODEL # EIZGS | Oct 25, 1998 | Substantially Equivalent |