FDA.report

Slip Trainer

Primary DI
G505MRST0
Brand
Slip Trainer
Company
M.A.S.S. Rehab, LLC
Model
Standard
Device description
Perturbation training device.
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
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IONExerciser, Non-Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G505MRST0PrimaryHIBCC0

GMDN Terms

TermDefinition
Balance boardA flat, rigid beam that is placed on the floor and upon which a patient with difficulties in balance (e.g., a paraplegic or a stroke victim) walks for balance training. It is slightly elevated off of the floor and is available in various widths; some types may provide a motion (e.g., rock) to increase the level of difficulty.

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
G505MRBHS0Balance Harness Standard2023-08-01
G505MRES0Easy StepStandard2023-08-01
G505MRHSH0Healing Solutions HarnessStandard2023-08-01
G505MRMS0M.A.S.S. StrapStandard2023-08-01
G505MRPH0Pediatric HarnessStandard2023-08-01
G505MRTB0M.A.S.S. Traction BeltStandard2023-08-01
G505MRUHB0Unloading Harness BariatricBariatric2023-08-01
G505MRUHS0Unloading HarnessStandard2023-08-01

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