Cleared Traditional

K213120 - OW100S (model OW100S-US) (FDA 510(k) Clearance)

Class I Physical Medicine device.

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

K213120 is an FDA 510(k) clearance for the OW100S (model OW100S-US). Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (Woodstock, US). The FDA issued a Cleared decision on October 12, 2022 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Tissue Regeneration Technologies, LLC Dba AS Softwave Trt devices

Submission Details

510(k) Number K213120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 115d · This submission: 380d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Msquared Associates, Inc.
Cherita James

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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