FDA.reportPublic FDA data

PARALLEL BAR,MOBILITY,POWER HT,10'H&W AD

Primary DI
00840314800350
Brand
PARALLEL BAR,MOBILITY,POWER HT,10'H&W AD
Company
Hausmann Enterprises, LLC
Model
1398
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRRBars, Parallel, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRRBars, Parallel, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314800350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314800350008403148003508403148003500840314800350

GMDN Terms#

Term, Definition table
TermDefinition
Parallel bar exerciser, poweredA mains electricity (AC-powered) exercise apparatus designed to assist a user in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which are electrically height and/or width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001892660
Device count
1
Premarket exempt
true
Serial number
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
00840314815125TGA-TENNIS ELBOW GEL/AIR XLONGHM74262025-01-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854798000465Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
00854798000472Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
00854798000489Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
00854798000496Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
00854798000502Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
00854798000519Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2026-01-22
G535DST0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTP0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTT0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTP0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTPX0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTS0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTX0DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DST1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTP1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTT1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTP1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTPX1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTS1DSTD.P.E MEDICAL LTD.IRR2026-01-20
G535DSTTX1DSTD.P.E MEDICAL LTD.IRR2026-01-20
00854798000298Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00854798000311Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00854798000328Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00854798000335Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00854798000342Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00854798000373Parallel Bars Electric Platform MountPIVOTAL HEALTH SOLUTIONS, INC.IRR2025-05-09
00840314800336PARALLEL BAR BARI,POWER H&W ADJ 10'Hausmann Enterprises, LLCIRR2022-08-16
00840314800343PARALLEL BAR,POWER HT,10'H&W ADJ,LEDHausmann Enterprises, LLCIRR2022-08-16