rebless

Primary DI
08800101600084
Brand
rebless
Company
H ROBOTICS INC.
Model
RHSW
Device description
Power switch
Published
2021-03-18
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
BXBExerciser, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800101600084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800101600084088001016000848800101600084

GMDN Terms

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

Regulatory Flags

DUNS number
695126303
Device count
1
DM exempt
true
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
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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