Bemer Therapy System Evo— 510(k) K231368

Substantially Equivalent

Bemer Int AG

FDA 510(k) clearance K231368 for Bemer Therapy System Evo, Substantially Equivalent on 2023-06-09. Applicant: Bemer Int AG. Device class: 2.

Clearance details

Applicant: Bemer Int AG
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2023-05-11
Decision date: 2023-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Triesen, LI

Download summary PDF View on FDA.gov ↗

Recent devices under product code NGX

K253790 — High Intensity Focused Electromagnetic Stimulation Device (FE60)2026-08-13
K253926 — Diacore2026-04-10
K253636 — Zionic Pro Max (EMS)2026-03-12
K253408 — CoolTone2026-01-16
K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)2025-12-09

More clearances from Bemer Int AG

K223919 — B.Light Clear Evo and B.Light Restore Evo2023-09-23
K210174 — BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set2021-02-04
K151834 — BEMER Classic Set, BEMER Pro-Set2017-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.