Data / Medical devices / United States / Drive DeVilbiss Healthcare

Drive DeVilbiss Healthcare: FDA-registered device maker in Perris, CA, United States, 10 510(k) clearances

Name: Drive DeVilbiss Healthcare FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Drive DeVilbiss Healthcare is registered with the FDA (registration 3043460907) in Perris, CA, United States. It lists 22 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 15, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Drive DeVilbiss Healthcare

FDA registration number: 3043460907
Address: 21511 Harvill Avenue, Perris, CA, United States, 92570
Owner or operator: Medical Depot Inc dba Drive DeVilbiss Healthcare (9040780)
Roles: Repackager or relabeler
First device listed: May 9, 2001
Registered through: 2026
Brand names listed: Gravity Mattress, Innerspring Mattress, Quick N Easy

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Repackager or relabeler	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Repackager or relabeler	accessdata.fda.gov
Adult Portable Bed Rails For Medical Purposes	QTC	1	Repackager or relabeler	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Repackager or relabeler	accessdata.fda.gov
Cane	IPS	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Chair And Table, Medical	KMN	1	Repackager or relabeler	accessdata.fda.gov
Chair, With Casters	INM	1	Repackager or relabeler	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Repackager or relabeler	accessdata.fda.gov
Crutch	IPR	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Flotation	KIC	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Repackager or relabeler	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Repackager or relabeler	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Repackager or relabeler	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Repackager or relabeler	accessdata.fda.gov
Stand, Infusion	FOX	1	Repackager or relabeler	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Repackager or relabeler	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2023	K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
June 14, 2021	K200466	Manual Wheelchair (Model W28)	IOR	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	accessdata.fda.gov
September 25, 2018	K181795	AST Model MA012 and MS019 Rehab Wheelchair	IOR	Substantially Equivalent	Sichuan Ast Medical Equipment Co., Ltd.	accessdata.fda.gov
March 23, 2018	K172648	Drive DeVilbiss iGo 2 Portable Oxygen Concentrator	CAW	Substantially Equivalent	Devilbiss Healthcare, LLC	accessdata.fda.gov
April 18, 2012	K112816	ZHENJIANG ASURE MECHANICAL WHEELCHAIR	IOR	Substantially Equivalent	Zhenjiang Assure Medical Equipment Co., Ltd.	accessdata.fda.gov
March 22, 2010	K094047	18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR	IOR	Substantially Equivalent	Modern Rehabilitation Solutions Co., Ltd.	accessdata.fda.gov
November 10, 2009	K091272	BESMED JET NEBULIZER BOTTLE SET	CAF	Substantially Equivalent	Besmed Health Business Corp	accessdata.fda.gov
October 7, 2008	K082784	JUMAO MANUAL WHEELCHAIR	IOR	Substantially Equivalent	Danyang Jumao Healthcare Equipment Co., Ltd.	accessdata.fda.gov
October 7, 2003	K031413	VIGORMIST COMPRESSOR NEBULIZER	BTI	Substantially Equivalent	Vega Technologies, Inc.	accessdata.fda.gov
February 23, 1993	K923888	DEVILBISS MODEL 5650 PULMO-AIDE	CAF	Substantially Equivalent	Devilbiss Health Care, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.