FDA.reportPublic FDA data

HoverMatt PROSWedge

Primary DI
00816299012828
Brand
HoverMatt PROSWedge
Company
Hovertech International
Model
PROSXL
Device description
Pair of XL positioning wedges
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816299012828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816299012828008162990128288162990128280816299012828

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Regulatory Flags#

DUNS number
942139841
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816299013191HoverSling Repositioning SheetHMSLING-39RS-HC2026-05-12
00816299013214HoverMatt SPU LinkHM39SPU-LNK-HC2026-05-12
00816299013238HoverMatt SPU LinkHM50SPU-LNK-HC2026-05-12
00816299013252HoverMatt SPU LinkHM34SPU-LNK-HC2026-05-12
00816299013276HoverSling Repositioning SheetHMSLING-50RSS-HC2026-05-12
00816299011500HoverCover SlideHMAC-SS-FULL-12026-01-12
00816299012965HoverMatt PROS AirPROS2-HM-HC2026-02-27
00816299012989HoverMatt PROS AirPROS2-HM-KIT2026-02-27
00816299013030HoverMatt PROS Air SlingPROS2-HMSL-KIT2026-02-27
00816299012958HoverMatt PROS AirPROS2-HM2026-02-27
00816299012972HoverMatt PROS AirPROS2-HM-HC2026-02-27
00816299012996HoverMatt PROS AirPROS2-HM-KIT2026-02-27
00816299013047HoverMatt PROS Air SlingPROS2-HMSL-KIT2026-02-27
00816299012194Single Patient Use HoverMattRGMT50FL-REGRGMT50FL-REG2023-01-16
00816299013016HoverMatt PROS Air SlingPROS2-HMSL2026-01-12
00816299010183HoverMatt T-Burg Arm ProtectorsHM-TBURG-AP2026-01-12
00816299011517HoverCover FittedHMAC-FIT-30-12026-01-12
00816299012934HoverCover Three-QTRHMAC-2002026-01-12
00816299010213HoverMatt T-BurgHM-TBURG-34HM-TBURG-342022-09-26
00816299010077HoverMattHM39DCHM39DC2016-07-30

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Primary DI, Brand, Company table
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00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166158DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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