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FDA 510(k)

C.T.M. MOBILITY SCOOTER HS515(3W)

K-Number: K110567 · 2011-04-22

ApplicantC.T.M. Homecare Product, Inc.
Decision Date2011-04-22
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C.T.M. MOBILITY SCOOTER HS515(3W) is the device name listed in this FDA 510(k) record. The listed applicant is C.T.M. Homecare Product, Inc.. It received FDA 510(k) clearance on 2011-04-22 under 510(k) number K110567. 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 HS515(3W)?

C.T.M. MOBILITY SCOOTER HS515(3W) is a medical device that received FDA 510(k) clearance on 2011-04-22. The listed applicant is C.T.M. Homecare Product, Inc.. The 510(k) number is K110567.

When did C.T.M. MOBILITY SCOOTER HS515(3W) receive FDA 510(k) clearance?

C.T.M. MOBILITY SCOOTER HS515(3W) received FDA 510(k) clearance on 2011-04-22, under 510(k) number K110567.

Who is the listed applicant for C.T.M. MOBILITY SCOOTER HS515(3W)?

The FDA 510(k) record lists C.T.M. Homecare Product, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.T.M. MOBILITY SCOOTER HS515(3W)?

The FDA product code for C.T.M. MOBILITY SCOOTER HS515(3W) is INI.

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Other records listing C.T.M. Homecare Product, Inc. 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.

K110395C.T.M. MOBILITY SCOOTER - MODEL HS 118K091418C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORIONK090735C.T.M. MOBILITY SCOOTER, HS-528K073686C.T.M. POWER CHAIR, MODEL HS-1500K070602C.T.M. MOBILITY SCOOTER# HS-265K070603C.T.M. MOBILITTY SCOOTER # HS-295

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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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product 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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