LiteWalk

FDA 510(k) clearance K192607 · decided 2019-12-19

Clearance details

K-number: K192607
Device name: LiteWalk
Applicant: Viasonix , Ltd.
Decision: Substantially Equivalent
Date received: 2019-09-20
Decision date: 2019-12-19
Days to decision: 90 days
Clearance type: Traditional
Product code: IRP
Device class: 2
Regulation number: 890.5650
Medical specialty: Physical Medicine
Advisory committee: Physical Medicine
Location: Ra'Anana, IL
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.