Venen-trainer (Model: FM150, SFM90)— 510(k) K203746

Name: FDA 510(k) clearance K203746
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Substantially Equivalent

Shenzhen Pango Electronic Co., Ltd.

FDA 510(k) clearance K203746 for Venen-trainer (Model: FM150, SFM90), Substantially Equivalent on 2021-11-10. Applicant: Shenzhen Pango Electronic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Pango Electronic Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2020-12-22
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

view all

K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

More clearances from Shenzhen Pango Electronic Co., Ltd.

view all

K200716 — Electronic Blood Pressure Monitor2020-12-04
K182597 — Infrared thermometer2019-04-03
K170151 — Electronic Blood Pressure Monitor2017-10-13
K161845 — Electronic Blood Pressure Monitor2017-07-31
K131558 — PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B62013-08-30

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