The only accurate weight-bearing monitoring system
for crutch walking and gait rehabilitation
COMEBACK MOBILITY | |
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Classification Name: | DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED |
Product Code: | IRN |
Device Class: | 2 |
Regulation Number: | 890.5575 |
Medical Specialty: | Physical Medicine |
Registered Establishment Name: | FISON. LLC |
Owner/Operator: | FISON. LLC |
Owner/Operator Number: | 10086071 |
Establishment Operations: | Contract Manufacturer |
FISON. LLC | |
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Proprietary Name: | Smart crutch tips |
Classification Name: | DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED |
Product Code: | IRN |
Device Class: | 2 |
Regulation Number: | 890.5575 |
Medical Specialty: | Physical Medicine |
Registered Establishment Name: | COMEBACK MOBILITY |
Registered Establishment Number: | 3021057146 |
Owner/Operator Number: | Comeback Mobility |
Owner/Operator Number: | 10083584 |
Establishment Operations: | Specification Developer |
COMEBACK MOBILITY | |
---|---|
Classification Name: | DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED |
Product Code: | IRN |
Device Class: | 2 |
Regulation Number: | 890.5575 |
Medical Specialty: | Physical Medicine |
Registered Establishment Name: | FISON. LLC |
Owner/Operator: | FISON. LLC |
Owner/Operator Number: | 10086071 |
Establishment Operations: | Contract Manufacturer |
FISON. LLC | |
---|---|
Proprietary Name: | Smart crutch tips |
Classification Name: | DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED |
Product Code: | IRN |
Device Class: | 2 |
Regulation Number: | 890.5575 |
Medical Specialty: | Physical Medicine |
Registered Establishment Name: | COMEBACK MOBILITY |
Registered Establishment Number: | 3021057146 |
Owner/Operator Number: | Comeback Mobility |
Owner/Operator Number: | 10083584 |
Establishment Operations: | Specification Developer |
Classification
Class II device, 890.5575 Powered external limb overload warning device.
FDA registration
Owner Operator Number: 10083584 COMEBACK MOBILITY registered as of Dec 6, 2021
Registration
Completed
Classification
Class II device, 890.5575 Powered external limb overload warning device.
FDA registration
Owner Operator Number: 10083584 COMEBACK MOBILITY registered as of Dec 6, 2021
Registration
Completed
97116
The patient has had an injury or condition that requires instruction in the use of a walker, crutches, or cane.
98975
Remote therapeutic monitoring (eg, respiratory system status, musculoskeletal system status, therapy adherence, therapy response); initial set-up and patient education on the use of equipment
98977
Device(s) supply with scheduled (eg, daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, every 30 days
90901
Should be billed when biofeedback training is provided. Biofeedback training consists of the amount of time that the biofeedback modality is attached to the patient with the feedback results to be used and/or analyzed by the patient and/or clinician
Weight-bearing tracking service to control the load on the injured leg during rehabilitation
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