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FDA 510(k)

HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1

K-Number: K071006 · 2007-05-21

ApplicantHeartway Medical Products Co., Ltd.
Decision Date2007-05-21
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 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 2007-05-21 under 510(k) number K071006. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1?

HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 is a medical device that received FDA 510(k) clearance on 2007-05-21. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K071006.

When did HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 receive FDA 510(k) clearance?

HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 received FDA 510(k) clearance on 2007-05-21, under 510(k) number K071006.

Who is the listed applicant for HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1?

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 ATTENDANT-CONTROLLED POWER CHAIR, TC1?

The FDA product code for HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 is ITI.

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Related Devices (Code: ITI)

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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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