SLENDERTONE CoreFit Abs 8, Type 734— 510(k) K180688

Name: FDA 510(k) clearance K180688
Creator: U.S. Food and Drug Administration
Published: 2018-10-25

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K180688 for SLENDERTONE CoreFit Abs 8, Type 734, Substantially Equivalent on 2018-10-25. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-03-15
Decision date: 2018-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NGX

view all

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 Bio-Medical Research, Ltd.

view all

K203513 — SLENDERTONE Evolve Abs, Type 7352021-02-10
DEN170049 — Innovo2018-11-06
K161974 — SLENDERTONE® Connect Abs, Type 5702016-11-01
K151903 — Slendertone connect Abs2015-11-06
K112934 — NEUROTECH RECOVERY2012-01-20

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