Little Wave Clik, Rogue XP, Little Wave XP, Spark— 510(k) K223527

Substantially Equivalent

Ki Mobility, LLC

FDA 510(k) clearance K223527 for Little Wave Clik, Rogue XP, Little Wave XP, Spark, Substantially Equivalent on 2023-08-31. Applicant: Ki Mobility, LLC.

Clearance details

Applicant: Ki Mobility, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2022-11-23
Decision date: 2023-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevens Point, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.