Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Klaxon (Twist); Klaxon (Twist R)

K-Number: K240267 · 2025-01-10

ApplicantKlaxon Mobility GmbH
Decision Date2025-01-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Klaxon (Twist); Klaxon (Twist R) is the device name listed in this FDA 510(k) record. The listed applicant is Klaxon Mobility GmbH. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K240267. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klaxon (Twist); Klaxon (Twist R)?

Klaxon (Twist); Klaxon (Twist R) is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Klaxon Mobility GmbH. The 510(k) number is K240267.

When did Klaxon (Twist); Klaxon (Twist R) receive FDA 510(k) clearance?

Klaxon (Twist); Klaxon (Twist R) received FDA 510(k) clearance on 2025-01-10, under 510(k) number K240267.

Who is the listed applicant for Klaxon (Twist); Klaxon (Twist R)?

The FDA 510(k) record lists Klaxon Mobility GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klaxon (Twist); Klaxon (Twist R)?

The FDA product code for Klaxon (Twist); Klaxon (Twist R) is ITI.

Other records listing Klaxon Mobility GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250748KLAXON (TWIST); KLAXON (TWIST R)K222502KLICK (VARIANTS: POWER, RACE, MONSTER)

Related Devices (Code: ITI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

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.

↑