DeviceClearance

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL— 510(k) K200583

Substantially Equivalent

Ki Mobility, LLC

FDA 510(k) clearance K200583 for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL, Substantially Equivalent on 2023-09-05. Applicant: Ki Mobility, LLC. Device class: 1.

Clearance details

Applicant
Ki Mobility, LLC
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stevens Point, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.