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FDA 510(k)

C.T.M. Mobility Scooter

K-Number: K162952 · 2017-05-03

ApplicantChien TI Enterprise Co., Ltd.
Decision Date2017-05-03
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C.T.M. Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Chien TI Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K162952. 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 C.T.M. Mobility Scooter?

C.T.M. Mobility Scooter is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Chien TI Enterprise Co., Ltd.. The 510(k) number is K162952.

When did C.T.M. Mobility Scooter receive FDA 510(k) clearance?

C.T.M. Mobility Scooter received FDA 510(k) clearance on 2017-05-03, under 510(k) number K162952.

Who is the listed applicant for C.T.M. Mobility Scooter?

The FDA 510(k) record lists Chien TI Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.T.M. Mobility Scooter?

The FDA product code for C.T.M. Mobility Scooter is INI.

Other records listing Chien TI Enterprise Co., Ltd. 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.

K192885C.T.M. Mobility Scooter HS-268K181344C.T.M Mobility Scooter

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.

K260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)Jiangsu Intco Medical Products Co., Ltd.K253600Scooter (YD-03)Yurob Rehabilitation Medical 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.

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