Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1831750

FEI Number

1831750

Entity Name

STRYKER MEDICAL

City/State/Country

Portage, MI, US

Establishment Address

3800 E. CENTRE AVE., Portage, MI 49002, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prime TC with Swing Away Prime TC IsoFlex Mattress Cover XPRT Mattress Cover CHG Prevention Surface Cover iBed Wireless with iBed awareness S3 MEDSURG BED w/ iBED WIRELESS, BED EXTENDER (ACCESSORY), MATTRESS EXTENDER (ACCESSORY), IV POLE (ACCESSORY) InTouch with iBed Wireless Leg Positioner Disposables SofCare Heel Care Boot MX-Pro Ambulance Cot Restraint straps (accessory) Stryker Eye Stretcher Chair Stryker Eye Surgery Stretcher "Gynnie" ObGyn Stretcher PowerPRO TL Ambulance Cot Stryker Fluoroscopy Stretcher PowerPRO Ambulance Cot Prime Series 5th Wheel Stretcher Stryker Stretcher Chair Stryker Trauma Stretcher Stryker Transport Stretcher M1 Roll-In System PerformancePRO-XT PowerPro-XT Prime Series Big Wheel Stretcher Performance-LOAD PerformancePRO Stryker Cot Fastener Arm board (Accessory) Stretcher Extender (Accessory) Pre-Op/Post-Op Head Extension (Accessory) X-Ray Cassette Holder (Accessory) HAVASU IV Pole (Accessory) Power-PRO 2 Prime X Prime Connect PowerPRO IT Ambulance Cot TREATMENT RECLINER Symmetry Plus Narrow Treatment Recliner Symnmetry Plus Treatment Recliner Prime X Zoom Prime Series Big Wheel Zoom Stretcher Prime Zoom Stretcher X-Ray Cassette Holder (Accessory) HAVASU IV Pole (Accessory) Stretcher Extender (Accessory) Restraint Strap (Accessory) CUB HAVASU IV Pole (Accessory) Sofcare Plus SPR Plus II Duogard Sofcare Companion Pump IsoFlex LAL AIR+ Pump SofCare manual handpump MV3 Bariatric Bed, Patient Helper (Accessory), IV Pole (Accessory) Xpedition Model 4701 Maternity Bed LD304 Birthing Bed Engage Medical Device Alarm Notification System Isolibrium Isolibrium PE Support Surface SofCare Chair Cushion (Bariatric) SofCare Chair Cushion Tru-Rize IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount Nara Platform Bed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2013-09-13
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	1994-09-21
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2010-12-27
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1977-12-29
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	1992-12-15
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2003-04-14
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2014-06-03
FMS	Bed, Pediatric Open Hospital	General Hospital	Class 2	880.5140	2001-08-08
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	1992-12-15
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2019-07-09
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2018-06-14
ILK	Transport, Patient, Powered	Physical Medicine	Class 2	890.5150	2023-04-10
HDD	Table, Obstetrical, Ac-Powered (And Accessories)	Obstetrics/Gynecology	Class 2	884.4900	2008-03-31
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-06-07
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	Class 2	890.5225	2006-11-30
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2010-11-02
INO	Chair, Positioning, Electric	Physical Medicine	Class 2	890.3110	2016-06-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	1992-12-15
NZG	Bassinet, Hospital	General Hospital	Class 2	880.5145	2015-05-11
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	1999-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K973527	Data Critical Corp.	CARDIO-PAGER SYSTEM	1998-03-31
K182637	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue XDS Software	2019-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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3012579728	FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO. LTD	Foshan City Guangdong, CN
3005026814	EVOLUTION TECHNOLOGIES, INC.	PORT COQUITLAM British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1831750. Last updated year: 2026. Please use registration number 1831750 when referencing this establishment in official correspondence.