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FDA 510(k)

C.T.M. MOBILITY SCOOTER, HS-528

K-Number: K090735 · 2009-07-06

ApplicantC.T.M. Homecare Product, Inc.
Decision Date2009-07-06
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C.T.M. MOBILITY SCOOTER, HS-528 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 2009-07-06 under 510(k) number K090735. 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, HS-528?

C.T.M. MOBILITY SCOOTER, HS-528 is a medical device that received FDA 510(k) clearance on 2009-07-06. The listed applicant is C.T.M. Homecare Product, Inc.. The 510(k) number is K090735.

When did C.T.M. MOBILITY SCOOTER, HS-528 receive FDA 510(k) clearance?

C.T.M. MOBILITY SCOOTER, HS-528 received FDA 510(k) clearance on 2009-07-06, under 510(k) number K090735.

Who is the listed applicant for C.T.M. MOBILITY SCOOTER, HS-528?

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, HS-528?

The FDA product code for C.T.M. MOBILITY SCOOTER, HS-528 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 118K110567C.T.M. MOBILITY SCOOTER HS515(3W)K091418C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORIONK073686C.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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