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510(k) K213120

OW100S (model OW100S-US) by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
September 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

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