FDA UDI In Commercial Distribution 🇺🇸 United States

THERA-Trainer bemo

DI: 04041925006230 · Model: 02.YY.ZZ · medica - Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
THERA-Trainer bemo
Primary DI
04041925006230
Version / Model
02.YY.ZZ
Catalog Number
A006-877
Company Name
medica - Medizintechnik GmbH
Labeler DUNS
328011325
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-16
Public Version
1
Public Version Date
2026-03-24
Public Version Status
New
Public Device Record Key
e5059c28-241c-4efe-9bfd-3f23edacb939

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BXB Exerciser, Powered

GMDN Terms

Code Name
36313 Continuous passive motion joint exerciser

Identifiers

Type ID
Primary 04041925006230