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FDA 510(k)

Powered Mobility Scooter (PMS105, GUT177, GCAT047)

K-Number: K252590 · 2025-11-21

ApplicantIntradin (Shanghai) Machinery Co., Ltd.
Decision Date2025-11-21
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered Mobility Scooter (PMS105, GUT177, GCAT047) is a medical device manufactured by Intradin (Shanghai) Machinery Co., Ltd.. It received FDA 510(k) clearance on 2025-11-21 under approval number K252590. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K252590.

When was Powered Mobility Scooter (PMS105, GUT177, GCAT047) approved by the FDA?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) received FDA 510(k) clearance on 2025-11-21, under approval number K252590.

What company makes Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) is manufactured by Intradin (Shanghai) Machinery Co., Ltd..

What is the FDA product code for Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

The FDA product code for Powered Mobility Scooter (PMS105, GUT177, GCAT047) is INI.

Related Clinical Trials

NCT07613502 Bio Leg: Advancing Mobility NOT_YET_RECRUITING NCT04786821 Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis COMPLETED NCT05644522 Nomad P-KAFO Study RECRUITING NCT06591559 Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays COMPLETED NCT03204513 Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction ACTIVE_NOT_RECRUITING NCT05776030 Multi-speed Ergonomic Wheelchair RECRUITING

Other Devices by Intradin (Shanghai) Machinery Co., Ltd.

K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) K243970Portable Wheelchair K250027Powered Mobility Scooter

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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