Ki Focus CRRecalls & reported problems

Ki Mobility, LLC · FOCUS MANUAL WHEELCHAIR · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850013379118), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Human-Device Interface Problem1
Use of Device Problem1

Patient problems

Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 17, 2025Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem
IT WAS STATED THE LEFT WHEEL LOCK WOULD NOT HOLD AND ENGAGE. THE USER WAS GOING TO TRANSFER FROM BED TO THE CHAIR AND WHEN HE WENT TO ENGAGE WHEEL LOCK. THE WHEEL LOCK SLIPPED, THE USER FELL FORWARD HITTING HIS HEAD ON A DRESSER CAUSING HIM TO CUT HIS HEAD AND REQUIRED STITCHES.
Patient problems: Laceration(s)
MAUDE report 21618031 ↗

Device details

UDI-DI	`00850013379118`
Brand	Ki
Model	Focus CR
Company	Ki Mobility, LLC
Product code	IOR · Wheelchair, Mechanical
Class	Class 1
FDA submission	K200583
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 27, 2026

Device type (GMDN): Push-rim manual wheelchair, non-bariatric

A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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