Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1954156

FEI Number

3002693132

Entity Name

Agiliti Health - Ellis

City/State/Country

ELLIS, KS, US

Establishment Address

204 W 2nd St, ELLIS, KS 67637, 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

Cushion, Flotation, powered Geri Air Powered Flotation Therapy Bed Immerse Pulsate Adapt Pedi Adapt Crib Alliance Sizewise Evolution Bed Essentia Sizewise Advantage Bed Bari-Rehab Bed Mighty Rest Rehab Bed Sizewise Behavioral Health Bed Sizewise Low Bed 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 Rotate Bed, Patient Rotation, Powered Big Turn

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2022-12-13
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2022-12-06
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2004-02-04
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2004-07-01
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	Class 2	890.5225	2022-12-06

Official Correspondent

Heidi Drafall

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
3029836575	Agiliti Health - Milwaukee	Wauwatosa, WI, US
2030732	Agiliti Health - Corona	CORONA, CA, US
1931307	Agiliti Health - Hays	Hays, KS, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1954156. Last updated year: 2026. Please use registration number 1954156 when referencing this establishment in official correspondence.