OmniCycle Connect

GUDID 04041925006186

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.

medica - Medizintechnik GmbH

Continuous passive motion joint exerciser
Primary Device ID04041925006186
NIH Device Record Key8e3eeb9e-ebb4-40da-a10d-3e97a6d405e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniCycle Connect
Version Model Number03.XX.XX
Company DUNS328011325
Company Namemedica - Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104041925006186 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-23
Device Publish Date2023-11-15

Devices Manufactured by medica - Medizintechnik GmbH

04041925005981 - THERA-Trainer toro2024-08-27 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
04041925006186 - OmniCycle Connect2023-11-23The 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.
04041925006186 - OmniCycle Connect2023-11-23 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
04041925002706 - THERA-Trainer tigo2023-10-31 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
04041925002713 - THERA-Trainer balo2023-10-31 THERA-Trainer balo is a standing aid with balance function, suitable for static-dynamic training of patients with limited standi
04041925002720 - THERA-Trainer coro2023-10-31 THERA-Trainer coro is a standing aid with balance function, suitable for static-dynamic training of patients with limited standi
04041925002775 - THERA-Trainer lyra2023-10-31 The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. T
04041925002812 - THERA-Trainer bemo2023-10-31
04041925002744 - Thera-trainer Mobi2023-10-11 Portable bicycle exerciser

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