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FDA 510(k)

HEARTWAY LIGHTWEIGHT POWER CHAIR, P15

K-Number: K071005 · 2007-05-22

ApplicantHeartway Medical Products Co., Ltd.
Decision Date2007-05-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 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 2007-05-22 under 510(k) number K071005. 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 LIGHTWEIGHT POWER CHAIR, P15?

HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K071005.

When did HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 receive FDA 510(k) clearance?

HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 received FDA 510(k) clearance on 2007-05-22, under 510(k) number K071005.

Who is the listed applicant for HEARTWAY LIGHTWEIGHT POWER CHAIR, P15?

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 LIGHTWEIGHT POWER CHAIR, P15?

The FDA product code for HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 is ITI.

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

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Related Devices (Code: ITI)

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.

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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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