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FDA 510(k)

HEARTWAY POWER MOBILITY SCOOTER, S11

K-Number: K101143 · 2010-05-26

ApplicantHeartway Medical Products Co., Ltd.
Decision Date2010-05-26
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEARTWAY POWER MOBILITY SCOOTER, S11 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 2010-05-26 under 510(k) number K101143. 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 HEARTWAY POWER MOBILITY SCOOTER, S11?

HEARTWAY POWER MOBILITY SCOOTER, S11 is a medical device that received FDA 510(k) clearance on 2010-05-26. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K101143.

When did HEARTWAY POWER MOBILITY SCOOTER, S11 receive FDA 510(k) clearance?

HEARTWAY POWER MOBILITY SCOOTER, S11 received FDA 510(k) clearance on 2010-05-26, under 510(k) number K101143.

Who is the listed applicant for HEARTWAY POWER MOBILITY SCOOTER, S11?

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 HEARTWAY POWER MOBILITY SCOOTER, S11?

The FDA product code for HEARTWAY POWER MOBILITY SCOOTER, S11 is INI.

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Other records listing Heartway Medical Products Co., Ltd. as applicant

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Related Devices (Code: INI)

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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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