Company ยท US
Sunrise Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2013. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITI | Wheelchair, Powered | 15 |
| IOR | Wheelchair, Mechanical | 10 |
| BZD | Ventilator, Non-Continuous (Respirator) | 6 |
| CAW | Generator, Oxygen, Portable | 5 |
| NFB | Conserver, Oxygen | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 |
| FRN | Pump, Infusion | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 |
| INI | Vehicle, Motorized 3-Wheeled | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2013 | K123975 | QUICKIE & ZIPPIE SERIES Sunrise Medical | IOR |
| Jan 26, 2010 | K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES Sunrise Medical | MNS |
| Sep 28, 2009 | K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST Sunrise Medical | BZD |
| Oct 28, 2008 | K082209 | DEVILBISS DV5M SMARTLINK SYSTEM Sunrise Medical | BZD |
| Aug 25, 2008 | K081468 | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES Sunrise Medical | CAW |
| Oct 1, 2007 | K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES Sunrise Medical | CAW |
| Sep 10, 2007 | K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR Sunrise Medical, Inc. | IOR |
| Sep 7, 2007 | K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES Sunrise Medical | BZD |
| Sep 25, 2006 | K062701 | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR Sunrise Medical, Inc. | ITI |
| Mar 17, 2006 | K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS Sunrise Medical | ITI |
| Feb 3, 2006 | K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES Sunrise Medical | CAW |
| Feb 11, 2005 | K043435 | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR Sunrise Medical | ITI |
| Feb 11, 2005 | K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES Sunrise Medical | BZD |
| Jan 14, 2005 | K042455 | DEVILBISS NASAL CPAP MASK, 9354 SERIES Sunrise Medical | BZD |
| Feb 20, 2004 | K032056 | BILEVEL CPAP, MODEL 9055 SERIES Sunrise Medical | BZD |
| May 9, 2003 | K031289 | QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 Sunrise Medical, Inc. | ITI |
| Jun 28, 2002 | K020932 | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR Sunrise Medical | CAF |
| May 15, 2001 | K011268 | BREEZY WHEELCHAIR, MODEL 300 Sunrise Medical, Inc. | IOR |
| May 15, 2001 | K010917 | POWER TILT AND RECLINE SYSTEM Sunrise Medical, Inc. | ITI |
| Dec 15, 2000 | K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR Sunrise Medical, Inc. | ITI |
| Nov 12, 1998 | K981885 | SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE Sunrise Medical, Inc. | INI |
| Nov 6, 1998 | K983677 | QUICKIE G SERIES, MODEL G-424 Sunrise Medical, Inc. | ITI |
| Nov 6, 1998 | K983520 | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD Sunrise Medical, Inc. | ITI |
| Nov 6, 1998 | K981462 | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 Sunrise Medical, Inc. | ITI |
| Oct 25, 1998 | K983639 | ZIPPIE GS, MODEL # EIZGS Sunrise Medical, Inc. | IOR |
| Oct 5, 1998 | K982989 | QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR Sunrise Medical, Inc. | IOR |
| Jan 27, 1998 | K974820 | BREEZY SERIES Sunrise Medical, Inc. | IOR |
| Nov 20, 1997 | K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES Sunrise Medical, Inc. | IOR |
| Aug 12, 1997 | K972797 | TOOL-LESS WHEEL CHAIR Sunrise Medical, Inc. | IOR |
| Jul 6, 1995 | K952641 | QUICKIE TSR Sunrise Medical, Inc. | IOR |
| Nov 28, 1994 | K944423 | POWER RECLINER Sunrise Medical, Inc. | ITI |
| Jun 18, 1993 | K925112 | BIO CLINIC UNDER PATIENT SCALE Sunrise Medical, Inc. | FRN |
| Aug 11, 1992 | K922205 | BIO THERAPY PLUS Sunrise Medical, Inc. | FNM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2010 | Sunrise Medical Inc Manual Wheelchairs with Transit System Option,
Model: Quickie LXI (EILXI),
Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA
Intended to provide mobility to persons restri Terminated |
IOR | K973673 |
| Feb 10, 2009 | Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. Terminated |
JCX | K982304 |
| Dec 30, 2008 | Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator
Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. Terminated |
CAW | K991722 |
| Sep 23, 2008 | Sunrise Medical Inc Sunrise Medical Quickie Groove Power Wheelchair with Transit option
The product is a powered wheelchair for human use. Terminated |
ITI | K060531 |
| Aug 23, 2008 | Sunrise Medical Inc Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13. Terminated |
ITI | K060531 |
| Aug 23, 2008 | Sunrise Medical Inc Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10 Terminated |
ITI | K060531 |
| Aug 14, 2007 | Sunrise Medical Inc Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays) Terminated |
ITI | K060531 |
| Apr 21, 2007 | Sunrise Medical 535D-X CF Continuous Flow Cylinder Terminated |
NFB | K020329 |
| Apr 21, 2007 | Sunrise Medical DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder Terminated |
NFB | K020329 |
| Oct 17, 2006 | Sunrise Medical DeVilbiss iFill Personal Oxygen Station model number 535D. Terminated |
CAW | K053240 |
| Feb 14, 2006 | Sunrise Medical Inc Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair;
Product is manufactured and distributed by
Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727 Terminated |
ITI | K031289 |
| May 3, 2005 | Sunrise Medical, Inc. Sunrise Hoyer Advance Patient lifts Terminated |
FSA | None listed |