OW100S (model OW100S-US)— 510(k) K213120

Name: FDA 510(k) clearance K213120
Creator: U.S. Food and Drug Administration
Published: 2022-10-12

Substantially Equivalent

Tissue Regeneration Technologies, LLC Dba AS Softwave Trt

FDA 510(k) clearance K213120 for OW100S (model OW100S-US), Substantially Equivalent on 2022-10-12. Applicant: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. Device class: 1.

Clearance details

Applicant: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 2021-09-27
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

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.