Instructions for Installing and Connecting Smart Crutch Tips

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

Certificates of Registration

Certificate of Registration
Certificate of Registration Secure
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Download Mobile App

ComeBack Mobility
For Patient

iPhone 14

Download Mobile App

ComeBack Mobility
For Patient

Patietn_phone

Download Mobile App

ComeBack Mobility
For Patient

Installing
Smart Crutch Tips

*If you completely unscrewed the nut:
– first instal the nut on the crutch,
– then the rubber gasket,
– then spin the Smart Crutch Tip

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

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

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

Regulations & Certificates

FDA_Contract Manufacture_Registered
FDA_Contract Develooper_Registered
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