# Intradin (Shanghai) Machinery Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 4 (2024–2025): 4 510(k) clearances
- Product codes: INI (3), ITI (1)
- 510(k) review time since 2016: median 86 days, against 111 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heartway Medical Products Co., Ltd.: 1 (https://510kreport.com/company/heartway-medical-products)

## Firms that cite its devices most
- Dongguan Smarfody Mobility Technology Co., Ltd.: 2 (https://510kreport.com/company/dongguan-smarfody-mobility-technology)

## Its most-cited devices
- K232692: Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) (2024), cited by 2
- K250027: Powered Mobility Scooter (2025), cited by 1

## Recent decisions
- K252590: Powered Mobility Scooter  (PMS105, GUT177, GCAT047) (Nov 21, 2025)
- K243970: Portable Wheelchair (Mar 7, 2025)
- K250027: Powered Mobility Scooter (Feb 21, 2025)
- K232692: Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) (Sep 5, 2024)

Source page: https://510kreport.com/company/intradin-shanghai-machinery