# K213120: OW100S (model OW100S-US)

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
- Decided: Oct 12, 2022 after 380 days
- Product code: ISA (Massager, Therapeutic, Electric)
- Device class: 1
- Regulation: 21 CFR 890.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 193 ancestors in all.
No later device cites it as a predicate yet.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210451: OrthoGold 100, Tissue Regeneration Technologies, LLC (2021) Summary page 4.

## Indications for use
The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase in local blood circulation - Activation of connective tissue

Source page: https://510kreport.com/device/K213120
Methodology: https://510kreport.com/methodology