OmniCycle Connect

Primary DI
04041925006186
Brand
OmniCycle Connect
Company
medica - Medizintechnik GmbH
Model
03.XX.XX
Device description
The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The system is used in a seated position, e.g. in a wheelchair or suitable therapy chair.The movement is managed by two drive units which differentiate in upper and lower extremities. The drive unit for lower extremities is limited in extent by the selected crank radius. The drive unit for upper extremities is limited to one crank radius. Both drive units are never moved simultaneously.The therapy drive units for leg and arm do drive a supportive accessory for legs (footrests) and arms (therapy grips, arm support or arm rest) in a circular motion. The different accessories are interchangeable by the operator.With the user interface the operator is able to select a training type (upper extremity or lower extremity training) which heads for related therapy drive unit.The medical device guarantees a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The device can be easily transported to different places of use or storage by means of castors and transport belt.The interfaces of the upper drive unit are designed in such a way that other accessory options are easy to attach. The requirements for the use of these accessories are derived from the degree of disability of the user.The training of the upper extremities should be possible as an option and does not have to be present as a matter of principle.
Published
2023-11-15
Public version status
New
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
04041925006186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041925006186040419250061864041925006186

GMDN Terms#

Term, Definition table
TermDefinition
Continuous passive motion joint exerciserA mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328011325
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041925006339PHS - XSGBS 01.YY.ZZA008-6852026-05-13
04041925006346PHS - SGBS 01.YY.ZZA008-6862026-05-13
04041925006353PHS - MGBS 01.YY.ZZA008-6872026-05-13
04041925006360PHS - LGBS 01.YY.ZZA008-6882026-05-13
04041925006377PHS - XLGBS 01.YY.ZZA008-6892026-05-13
04041925006117PHS - XSGBS 01.YY.ZZA008-6852024-11-14
04041925006124PHS - SGBS 01.YY.ZZA008-6862024-11-14
04041925006131PHS - MGBS 01.YY.ZZA008-6872024-11-14
04041925006148PHS - LGBS 01.YY.ZZA008-6882024-11-14
04041925006155PHS - XLGBS 01.YY.ZZA008-6892024-11-14
04041925006230THERA-Trainer bemo02.YY.ZZA006-8772026-03-16
04041925006247THERA-Trainer bemo02.YY.ZZA006-8782026-03-16
04041925002812THERA-Trainer bemo01.XX.XX2023-10-23
04041925006254THERA-Trainer toro01.05.ZZ2025-12-16
04041925006261THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006278THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006285THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006308OmniCycle® Revo 01.05.ZZ2025-12-16
04041925006315OmniCycle® Revo01.05.ZZ2025-12-16
04041925006193THERA-Trainer toro01.YY.XX2025-09-04

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