510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ki Mobility

Stevens Point, WI, US

Ki Mobility appears in FDA device records in Stevens Point, WI. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Ki Mobility between 2006 and 2023. The busiest year on record is 2023, with 4. The most recent is 2023, with 4.

Clearances by year, as a table
510(k) clearance decisions for Ki Mobility, by decision year
YearClearances
20061
20234
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K201869Ki Power Tilt SystemITISubstantially Equivalent
K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLIORSubstantially Equivalent
K223533Little Wave Arc; Little Wave FlipLBESubstantially Equivalent
K223527Little Wave Clik, Rogue XP, Little Wave XP, SparkIORSubstantially Equivalent
K062660CATALYSYIORSubstantially Equivalent

Registered establishments

FDA registered establishments for Ki Mobility, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30059053213005905321Ki Mobility5201 WOODWARD DR, Stevens Point, WI 54481 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0467-2022Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.Class IIITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain