FDA.reportPublic FDA data

AirWedge

Primary DI
00816299011388
Brand
AirWedge
Company
Hovertech International
Model
HTPP-200
Catalog number
HTPP-200
Device description
HoverTech Dual Chamber Inflatable Wedge
Published
2016-07-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNGLIFT, PATIENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121287000HT-WEDGED.T. Davis Enterprises Ltd. T/A Hovertech Int'L2012-10-03FNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816299011388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816299011388008162990113888162990113880816299011388

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width23Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)471-2776info@hovermatt.com

Regulatory Flags#

DUNS number
942139841
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816299013337HoverMatt PROSWedgePROS-WH2026-07-06
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
00816299012828HoverMatt PROSWedgePROSXL2026-01-12
00816299012934HoverCover Three-QTRHMAC-2002026-01-12

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