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FDA 510(k)

Auto Folding Scooter, S21F

K-Number: K220227 · 2022-10-12

Decision Date2022-10-12
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Auto Folding Scooter, S21F is the device name listed in this FDA 510(k) record. The listed applicant is Heartway Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K220227. 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 Auto Folding Scooter, S21F?

Auto Folding Scooter, S21F is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K220227.

When did Auto Folding Scooter, S21F receive FDA 510(k) clearance?

Auto Folding Scooter, S21F received FDA 510(k) clearance on 2022-10-12, under 510(k) number K220227.

Who is the listed applicant for Auto Folding Scooter, S21F?

The FDA 510(k) record lists Heartway Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auto Folding Scooter, S21F?

The FDA product code for Auto Folding Scooter, S21F 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

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