DEVICE: THERA-Trainer bemo (04041925006247)

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Device Identifier (DI) Information

THERA-Trainer bemo
02.YY.ZZ
In Commercial Distribution
A006-878
medica - Medizintechnik GmbH
04041925006247
GS1

1
328011325 *Terms of Use
The THERA-Trainer bemo 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 medical device is used for leg exercise in a lying or almost lying position, e.g. in a hospital/nursing bed or on a therapy couch, and for upper body exercise in a lying, almost lying or seated position, e.g. in a hospital/nursing bed, therapy couch, chair or wheelchair. The movement is managed by the drive unit and is limited in extent by the selected crank radius. The drive of the upper extremities and the lower extremities is managed by the same drive unit. The drive unit will never move the arms and legs simultaneously. The drive unit drives a positioning device for legs (footrests) and arms (therapy grips) in a circular motion. The different positioning devices should be easily interchangeable by the operator. With the chassis and the electronic lifting column, the drive unit can be positioned individually on the patient. The wide chassis with four lockable castors ensures that the THERA-Trainer bemo does not slip or tip over, both during exercise preparation and during exercise. Through four lockable castors, the THERA-Trainer bemo can be easily transported to different places of use or storage.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36313 Continuous passive motion joint exerciser
A 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.
Active false
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FDA Product Code

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Product Code Product Code Name
BXB Exerciser, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

094a54a9-23f8-4230-a66f-55b06ed4f737
March 24, 2026
1
March 16, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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