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)

Scooter

K-Number: K182471 · 2019-07-10

Decision Date2019-07-10
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K182471. 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 Scooter?

Scooter is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. The 510(k) number is K182471.

When did Scooter receive FDA 510(k) clearance?

Scooter received FDA 510(k) clearance on 2019-07-10, under 510(k) number K182471.

Who is the listed applicant for Scooter?

The FDA 510(k) record lists Tianjin Kepler Vehicle Industry Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scooter?

The FDA product code for Scooter is INI.

Related Devices (Code: INI)

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.

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.