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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 the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. It received FDA 510(k) clearance on 2022-10-12 under 510(k) 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. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. The 510(k) number is K213120.

When did OW100S (model OW100S-US) receive FDA 510(k) clearance?

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

Who is the listed applicant for OW100S (model OW100S-US)?

The FDA 510(k) record lists Tissue Regeneration Technologies, LLC Dba AS Softwave Trt as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K220538DolorClast RadialE.M.S Electro Medical Systems S.AK210451OrthoGold 100Tissue Regeneration Technologies, LLC

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.

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