FDA.reportPublic FDA data

Balance Harness

Primary DI
G505MRBHS0
Brand
Balance Harness
Company
M.A.S.S. Rehab, LLC
Model
Standard
Device description
Balance harness for balance training activities
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IODComponents, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G505MRBHS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603101416
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G505MRES0Easy StepStandard2023-08-01
G505MRHSH0Healing Solutions HarnessStandard2023-08-01
G505MRMS0M.A.S.S. StrapStandard2023-08-01
G505MRPH0Pediatric HarnessStandard2023-08-01
G505MRST0Slip TrainerStandard2023-08-01
G505MRTB0M.A.S.S. Traction BeltStandard2023-08-01
G505MRUHB0Unloading Harness BariatricBariatric2023-08-01
G505MRUHS0Unloading HarnessStandard2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"Hausmann Enterprises, LLCIOD2025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"Hausmann Enterprises, LLCIOD2025-04-14
00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
00810113574356ViveVIVE HEALTH LLCIOD2024-07-17
00810113577296ViveVIVE HEALTH LLCIOD2024-07-17
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
00057475571184BIOS LivingThermor LtdIOD2023-09-18
10057475571181BIOS LivingThermor LtdIOD2023-09-18
00810113573403ViveVIVE HEALTH LLCIOD2023-08-23
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
00818323029529ViveVIVE HEALTH LLCIOD2023-08-02
00818323029536ViveVIVE HEALTH LLCIOD2023-08-02
10818323029526ViveVIVE HEALTH LLCIOD2023-08-02
10818323029533ViveVIVE HEALTH LLCIOD2023-08-02
G505MRHSH0Healing Solutions HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
10810041982350VIVEVIVE HEALTH LLCIOD2023-06-30
07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21
072900197338673DTutorMEDITOUCH LTDIOD2023-06-21
07290019733874LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733881LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733898ArmTutorMEDITOUCH LTDIOD2023-06-21