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FDA 510(k)

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

K-Number: K232692 · 2024-09-05

ApplicantIntradin (Shanghai) Machinery Co., Ltd.
Decision Date2024-09-05
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) is a medical device manufactured by Intradin (Shanghai) Machinery Co., Ltd.. It received FDA 510(k) clearance on 2024-09-05 under approval number K232692. 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 (Models: PMS101, GUT112, PMS103, GUT140)?

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) is a medical device that received FDA 510(k) clearance on 2024-09-05. It is manufactured by Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K232692.

When was Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) approved by the FDA?

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) received FDA 510(k) clearance on 2024-09-05, under approval number K232692.

What company makes Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)?

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) is manufactured by Intradin (Shanghai) Machinery Co., Ltd..

What is the FDA product code for Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)?

The FDA product code for Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) 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

Related PubMed Literature

PMID: 34657930 Editorial: Global Initiatives Support the Use and Regulation of Digital Health Technology During the COVID-19 Pandemic. Medical science monitor : international medical journal of experimental and clinical research (2021)

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

K252590Powered Mobility Scooter (PMS105, GUT177, GCAT047) 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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