FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IODComponents, Exercise

Product Code Classifications

CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G505MRBHS0PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
603101416
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00840314816108STAIRS,TIMBER,MINI STRAIGHT,2 6"STEPS,3Hausmann Enterprises, LLCIOD2025-04-14
00840314816122STAIRS,TIMBER,SINGLE-SIDE,4 6"STEPSHausmann Enterprises, LLCIOD2025-04-14
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
10057475571181BIOS LivingThermor LtdIOD2023-09-18
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
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
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
07290019733904ArmTutorMEDITOUCH LTDIOD2023-06-21
07290019733911HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733928HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733935HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733942HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733959HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733966HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733973HandTutorMEDITOUCH LTDIOD2023-06-21