Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)— 510(k) K232692

Name: FDA 510(k) clearance K232692
Creator: U.S. Food and Drug Administration
Published: 2024-09-05

Substantially Equivalent

Intradin (Shanghai) Machinery Co., Ltd.

FDA 510(k) clearance K232692 for Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140), Substantially Equivalent on 2024-09-05. Applicant: Intradin (Shanghai) Machinery Co., Ltd.. Device class: 2.

Clearance details

Applicant: Intradin (Shanghai) Machinery Co., Ltd.
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2023-09-05
Decision date: 2024-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code INI

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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 Intradin (Shanghai) Machinery Co., Ltd.

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K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047)2025-11-21
K243970 — Portable Wheelchair2025-03-07
K250027 — Powered Mobility Scooter2025-02-21

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.