Cleared Traditional

OW100S (model OW100S-US)

K213120 · Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · Physical Medicine
Oct 2022
Decision
380d
Days
Class 1
Risk

About This 510(k) Submission

K213120 is an FDA 510(k) clearance for the OW100S (model OW100S-US), a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (Woodstock, US). The FDA issued a Cleared decision on October 12, 2022, 380 days after receiving the submission on September 27, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K213120 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2021
Decision Date October 12, 2022
Days to Decision 380 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660