Weight-Bearing Tracking Service

The only accurate weight-bearing monitoring system
for crutch walking and gait rehabilitation

60sec

Regulations & Certificates

FDA_Contract Manufacture_Registered
FDA_Contract Develooper_Registered
QMS ISO 9001 2015 Registred Logo CBM Website
QMS ISO 27001 2013 Registred Logo CBM Website.png
HIPAA Compliance Verification-Seal-of-compliance Logo CBM Website
Clinically Validated Logo

Regulations & Certificates

fda
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

fda
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

Regulations & Certificates

FDA Spec Developer

fda
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

FDA

fda
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

Reimbursement

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

How Smart Crutch Tip Devices Work

Patient adheres to WB program using feedback cues from tips and app. Data is sent to doctor’s phone and PC

Doctor sets weight bearing (WB) program for duration of patient’s recovery

Patient adjusts the load on injured leg according to doctor’s instructions

Doctor monitors how the patient loads the injured leg, addresses patient concerns, and adapts program to patient’s needs

Testimonials & Quotes

Doctor’s Opinion

Orthopedic Trauma Surgery
Chief of Trauma Division in NYU Langone Health
23+ Yrs Experience

“It gives them immediate feedback and teaches them had to weight bear properly and follow up the follows a program that I prescribed gives me feedback”

CSU Prof. & Assoc. Director Physical Therapy

“It gives everybody an opportunity to just have some more feedback”

Maastricht University Medical Center, the Netherlands. Does research in Surgery and Traumatology. Current project – ‘Permissive weight bearing’

“With the feedback patients gets from the Crutches, they will back to walk 8 weeks sooner”

Doctor of Physical Therapy, Regional Director
Moriarty Physical Therapy

“The biggest issue for me is that people aren’t listening, so it’s an issue of not enough pressure or too much pressure. With teenagers it’s a little bit less of «too much», it’s a matter of putting enough weight to it, so I can track it. I can see their percent, so when they come I can say: «Hey, you are not doing enough. You’ve make a thousand steps the first week and week 2 you kinda fall off. You have to stop your game up and get more compliance to put more pressure or ask them not to put too much pressure”

PT, DPT, CSCS, USAW, SFMA, TPI, Clinical Director Professional Care Physical Therapy

“The issue arise is that one the patient foot is out of the scale, really there is no other way to tell how much weight they are actually putting. There is no objective medical founded”

During lower limb rehabilitation

PWB protocol shorten the time to full weight bearing in 6 weeks together with biofeedback device providing the real-time feedback and achieve optimal compliance

Rehabilitation must balance the limitation of weight-bearing in order to protect the surgical fixture, with increasing weight-bearing to facilitate the repetitive stimulation of bone growth

Biofeedback devices are superior to other methods in enabling patients to comply with partial weight-bearing

The AO guideline for postoperative management of tibial plateau fractures was formulated about 50 years ago and suggests restricted weight bearing for 12 weeks

Patients frequently do not follow the instructions despite their willingness to comply because the difficulty in assessing the weight borne

Orthopedic surgeons are currently trained to prescribe non-weight-bearing for 6 weeks post-surgery of the injured limb

Testimonials & Quotes

 Patient Reviews

How Smart Crutch Tip Devices Work

Patient adheres to WB program using feedback cues from tips and app. Data is sent to doctor’s phone and PC

Doctor sets weight bearing (WB) program for duration of patient’s recovery

Patient adjusts the load on injured leg according to doctor’s instructions

Doctor monitors how the patient loads the injured leg, addresses patient concerns, and adapts program to patient’s needs

Why Partner with Us?

Comeback Mobility makes a breakthrough in orthopedics providing new opportunities for telehealth services

Comeback Mobility makes a breakthrough in orthopedics providing new opportunities for telehealth services

Patient

  • Instant feedback for each step
  • Optimal recovery time
  • Reduce risk of complications

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Doctor

  • Increase patient satisfaction with delivered services
  • Real time objective gait data helps direct patient recovery & Protect against unfounded complaints
  • Deliver health promotion initiatives aimed at: Educating patients about proper weight-bearing

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Clinic

  • Cost-efficient and time-efficient approach
  • New income opportunities
  • Decreased rates of hospital readmissions and returning visits due to complications

Smart Crutch Tips System