Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030732

FEI Number

3000204953

Entity Name

Agiliti Health - Corona

City/State/Country

CORONA, CA, US

Establishment Address

252 MARIAH CIR., CORONA, CA 92879, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RAYE'S, inc dba Sizewise Manufacturing (Owner Number: 1931307)

Owner / Operator Contact Address

500 Commerce Pkwy, Hays, KS 67601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mattress Cover CoreShield Medtronic Situate Body Scanner Alternating Pressure Air Flotation Systems NPT3 Adapt Convertible Adapt Air Pro Alternate Platinum 6000 Alternating Pressure Air Flotation Overlay Systems NPT4 Dabir Surgical System Mighty Air Adapt Air Capillaire OR Dabir Patient Care Plus Capillaire OR Lithotomy Capillaire ST Capillaire SS Capillaire OR Pedi Capillaire Crib Powered Flotation Therapy Bed Immerse Pulsate Adapt Pedi Adapt Crib NP Trio Crib Sizewise Victory Series Mattresses Sizewise NP Mattresses Sizewise Hercules Foam Mattress Replacement NP Adjust EX NP Adjust ST NP Trio BH NP Adjust NP Duo NP Adjust BH NP Trio ST NP Gel Crib NP Trio NP Trio EX NP Duo ST Cushion, Flotation, powered Geri Air

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-12-10
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2020-12-10
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2020-12-10
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2020-12-10
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	2020-12-10
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2004-07-01
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2022-12-06
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2020-12-10
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2020-12-10
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2022-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RAYE'S, inc dba Sizewise Manufacturing

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034243939	RASMUSSEN DE TECATE S.A. DE C.V.	Tecate Baja California, MX
1954156	Agiliti Health - Ellis	ELLIS, KS, US
3029836575	Agiliti Health - Milwaukee	Wauwatosa, WI, US
1931307	Agiliti Health - Hays	Hays, KS, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15

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3033883981	NINGBO JIAQI APPAREL CO., LTD	Ningbo Zhejiang, CN
2031723	SIGMA SUPPLY & DISTRIBUTION, INC.	GLENDALE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030732. Last updated year: 2026. Please use registration number 2030732 when referencing this establishment in official correspondence.