# K210451: OrthoGold 100

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies, LLC
- Decided: May 5, 2021 after 78 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: 15 generations back to K943450 (1995). 192 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173692: D-Actor 200 Vibration Massage System, Storz Medical AG (2018) Summary page 5.

## Most influential descendants
- K210166: Omnispec ED1000 (2023), 0 descendants of its own
- K213120: OW100S (model OW100S-US) (2022), 0 descendants of its own

## Indications for use
The OrthoGold 100 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/K210451
Methodology: https://510kreport.com/methodology