Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OW100S (model OW100S-US)

K-Number: K213120 · 2022-10-12

ApplicantTissue Regeneration Technologies, LLC Dba AS Softwave Trt
Decision Date2022-10-12
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OW100S (model OW100S-US) is a medical device manufactured by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. It received FDA 510(k) clearance on 2022-10-12 under approval number K213120. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OW100S (model OW100S-US)?

OW100S (model OW100S-US) is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. The 510(k) number is K213120.

When was OW100S (model OW100S-US) approved by the FDA?

OW100S (model OW100S-US) received FDA 510(k) clearance on 2022-10-12, under approval number K213120.

What company makes OW100S (model OW100S-US)?

OW100S (model OW100S-US) is manufactured by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt.

What is the FDA product code for OW100S (model OW100S-US)?

The FDA product code for OW100S (model OW100S-US) is ISA.

Related Devices (Code: ISA)

K182682OrthoGold 100Tissue Regeneration Technologies K173692D-Actor 200 Vibration Massage SystemStorz Medical AG K210451OrthoGold 100Tissue Regeneration Technologies, LLC K220538DolorClast RadialE.M.S Electro Medical Systems S.A K221865BTL-094BTL Industries, Inc. K210166Omnispec ED1000Medispec, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑