FDA.reportPublic FDA data

TGA-TENNIS ELBOW GEL/AIR XLONG

Primary DI
00840314815125
Brand
TGA-TENNIS ELBOW GEL/AIR XLONG
Company
Hausmann Enterprises, LLC
Model
HM7426
Device description
TGA-TENNIS ELBOW GEL/AIR XLONG SKU HM7426
Published
2025-01-31
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
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314815125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314815125008403148151258403148151250840314815125

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001892660
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314812667B-COOL COLD THERAPY WRAP UNIVHM33302025-01-01
00840314812728"B-COOL CRYO WRAP 24"" W/2,2.0 PKS"HM33972025-01-01
00840314816023B-COOL KNEE WRAP W/2, 2.0 PKSHM33822025-01-01
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"15262025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"15272025-04-14
00840314811134SPORT-TRAC KNEE STRAP LGHM01242025-01-31
00840314811417ANKLIZER PUMP AIR WALKER LGHM03342025-01-31
00840314812339"B-COOL KNEE IMMOB 20"" W/POCKETS"HM26422025-01-31
00840314815118TGA-TENNIS ELBOW GEL/AIR REGHM74252025-01-31
00840314812285F8X LACER ANKLE W/STAYS SMHM25322025-01-02
00840314812308F8X LACER ANKLE W/STAYS LGHM25342025-01-02
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHM00192025-01-01
00840314811165ELASTIC ANKLE SUPPORT SMHM01302025-01-01
00840314811172ELASTIC ANKLE SUPPORT MDHM01312025-01-01
00840314811189ELASTIC ANKLE SUPPORT LGHM01322025-01-01
00840314811196ELASTIC ANKLE SUPPORT XLHM01332025-01-01
00840314811202ELASTIC ELBOW SUPPORT SMHM01342025-01-01
00840314811219ELASTIC ELBOW SUPPORT MDHM01352025-01-01
00840314811226ELASTIC ELBOW SUPPORT MDHM01362025-01-01
00840314811233ELASTIC ELBOW SUPPORT XLHM01372025-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20