FDA.reportPublic FDA data

Advanced Wave HX, Hercules Mattress System

Primary DI
00819552022473
Brand
Advanced Wave HX, Hercules Mattress System
Company
MOREL COMPANY, LLC., THE
Model
Revision B
Device description
"Hercules Patient Repositioning Device with Advanced Wave HX Controller and Mattress - Pneumatic, Revision B, 35"" Width, 84"" Length"
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819552022473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819552022473008195520224738195520224730819552022473

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length84Inch
Width35Inch

Contacts#

Phone, Email table
PhoneEmail
812-932-6100joe@morelcompany.com

Regulatory Flags#

DUNS number
079202952
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819552022336Hercules Mattress"Mattress, Kap Medical, Pneumatic, Revision B, 35"MKPB542025-12-17
00819552022343Hercules Air Mattress ControllerController, Kap Medical, Revision ACKA2025-12-17
M988DFSA3NHerculesDFSA3NNA2017-02-12
M988DFSA3RHerculesDFSA3RNA2017-02-12
M988DFSA5HerculesDFSA5NA2016-05-11
M988DFSA9HerculesDFSA9NA2016-05-11
M988DVSA5HerculesDVSA5NA2016-05-11
00819552020004HerculesDFSA3NNA2017-12-07
00819552020042HerculesDFSA9NA2017-12-13
00819552020059HerculesDVSA5NA2017-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841447197966INVACARE® DLX SERIES BED RAILINVACARE CORPORATIONFNL2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEINVACARE CORPORATIONFNL2026-09-22
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500071SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500088DALTONXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
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06975084500415SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500422SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500439SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500446SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500453SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500460SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19