# K221865: BTL-094

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Apr 14, 2023 after 291 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)
- K173692: D-Actor 200 Vibration Massage System, Storz Medical AG (2018) Summary page 5.
- K220538: DolorClast Radial, E.M.S Electro Medical Systems S.A (2022). Cleared while this submission was under review Summary page 5.

## Indications for use
BTL-094 is indicated to be used for: - Relief of minor muscle aches and pains. - Temporary increase in local blood circulation. - Activation of connective tissue.

Source page: https://510kreport.com/device/K221865
Methodology: https://510kreport.com/methodology