Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010388769

FEI Number

3010388769

Entity Name

THE MOREL COMPANY

City/State/Country

Batesville, IN, US

Establishment Address

300 Winding Way, Batesville, IN 47006, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

The Morel Company (Owner Number: 10044676)

Owner / Operator Contact Address

300 Winding Way, Batesville, IN 47006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hercules Sheet Hercules Patient Repositioner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2021-11-19
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-07-12

Official Correspondent

Steven Hollingsworth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Morel Company

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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

Similar Registrations

Registration Number	Establishment Name	Location
3006635905	WRIGHT PRODUCTS, INC.	DECATUR, IL, US
3016661700	SKYLLA EUROPE BV	Geleen Limburg, NL
2921578	MIZUHO ORTHOPEDIC SYSTEMS, INC.	UNION CITY, CA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3042872922	HENGXIN (VN) MEDICAL DISPOSABLES CO., LTD.	Trang Bang Tay Ninh, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010388769. Last updated year: 2026. Please use registration number 3010388769 when referencing this establishment in official correspondence.