AccessGUDID - DEVICE: FOCUS PT (00850013379255)

GUDID

Device Identifier (DI) Information

Brand Name: FOCUS PT
Version or Model: FPT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KI MOBILITY, LLC

Primary DI Number: 00850013379255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 609305656 *Terms of Use

Device Description: THE KI POWER TILT SYSTEM PROVIDES POWER CONTROL OF TILT POSITION IN A MANUAL WHEELCHAIR.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57978	Wheelchair recliner, battery-powered	A battery-powered mobile device designed to tilt (recline) a standard type wheelchair and occupant (not bariatric) to enable healthcare providers give treatment at a degree of tilt most efficient for them. The device includes a platform onto which the wheelchair/occupant is reversed and secured, and rechargeable batteries that drive an electric motor to power the tilting mechanism. It may include additional back- and headrest and may be moved on wheels for repositioning within a room or facility. It is used for treatments in dentistry, ophthalmology, maxillofacial and ear/nose/throat (ENT), podiatry (including diabetic foot care), physical therapy, and personal care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201869	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26846244-7709-416e-bc60-bc5405bffdfc
Public Version Date: November 01, 2023
Public Version Number: 1
DI Record Publish Date: October 24, 2023