Solax Electric Scooter (Models: S204311M, S204161, S204143)— 510(k) K190737

Name: FDA 510(k) clearance K190737
Creator: U.S. Food and Drug Administration
Published: 2021-05-10

Substantially Equivalent

Dongguan Prestige Sporting Goods Co., Ltd.

FDA 510(k) clearance K190737 for Solax Electric Scooter (Models: S204311M, S204161, S204143), Substantially Equivalent on 2021-05-10. Applicant: Dongguan Prestige Sporting Goods Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dongguan Prestige Sporting Goods Co., Ltd.
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2019-03-22
Decision date: 2021-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code INI

view all

K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon))2026-08-10
K260176 — Mobility Scooter (W3483, W3483A)2026-08-10
K261232 — IERO Mobility Scooter (IERO-01)2026-07-14
K261163 — Mobility Scooter (R200)2026-07-07
K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F)2026-06-08

More clearances from Dongguan Prestige Sporting Goods Co., Ltd.

view all

K192190 — Solax Electric Scooter2021-04-23
K200978 — Electric Wheelchair (Model: S7110)2021-04-16
K202632 — Electric wheelchair (S7204/S7205)2021-04-08
K201508 — Infrared Thermometer2021-03-09
K202549 — Solax Electric Scooter (Model: S202261B)2021-02-26

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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