Cleared Traditional

K192607 - LiteWalk
(FDA 510(k) Clearance)

K192607 · Viasonix , Ltd. · Physical Medicine

Dec 2019

Decision

90d

Days

Class 2

Risk

K192607 is an FDA 510(k) clearance for the LiteWalk, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on December 19, 2019, 90 days after receiving the submission on September 20, 2019. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K192607 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2019
Decision Date	December 19, 2019
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF