# K220538: DolorClast Radial

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Jul 11, 2022 after 136 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.
1 later device descends from it; 1 cites it directly.
0 of 194 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 4.

## Most influential descendants
- K221865: BTL-094 (2023), 0 descendants of its own

## Indications for use
The DolorClast® Radial is indicated for: Relief of minor muscle aches and pains Temporary increase in local blood circulation Activation of connective tissue

Source page: https://510kreport.com/device/K220538
Methodology: https://510kreport.com/methodology