Electromagnetic Stimulation Systems— 510(k) K232409

Name: FDA 510(k) clearance K232409
Creator: U.S. Food and Drug Administration
Published: 2024-04-10

Substantially Equivalent

Shanghai Apolo Medical Technology Co., Ltd.

FDA 510(k) clearance K232409 for Electromagnetic Stimulation Systems, Substantially Equivalent on 2024-04-10. Applicant: Shanghai Apolo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Apolo Medical Technology Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2023-08-10
Decision date: 2024-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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 Shanghai Apolo Medical Technology Co., Ltd.

view all

K260256 — Q-Switched Nd: YAG Laser Systems2026-05-04
K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298)2026-04-09
K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)2025-07-02
K221770 — Fiber Laser Treatment System2022-10-13
K203395 — Platform treatment system2022-01-28

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