FDA.reportPublic FDA data

rebless

Primary DI
08800101600084
Brand
rebless
Company
H ROBOTICS INC.
Model
RHSW
Device description
Power switch
Published
2021-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800101600084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800101600084088001016000848800101600084

GMDN Terms#

Term, Definition table
TermDefinition
Ankle continuous passive motion exerciserA mains electricity (AC-powered) device designed to continuously move the ankle joint (e.g., flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. The device typically consists of a motorized carriage with straps to hold and move the leg/ankle, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; digital displays, manual/automated safety capabilities, and other features may also be included. CPM is believed to stimulate articular tissues and circulation of synovial fluid, and to reduce joint oedema.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695126303
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800101600183rebless (Model: RHDB)RHDB12023-10-30
08800101600169rebless planarRPLSW2023-08-21
08800101600039reblessRHSW2021-03-18
08800101600046reblessRHSW2021-03-18
08800101600053reblessRHSW2021-03-18
08800101600060reblessRHSW2021-03-18
08800101600077reblessRHSW2021-03-18
08800101600091reblessRHSW2021-03-18
08800101600107reblessRHSW2021-03-18
08800101600015reblessRHSW2021-03-16
08800101600022reblessRHSW2021-03-16

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Primary DI, Brand, Company table
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04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
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