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FDA 510(k)

HEARTWAY POWER CHAIR, P23

K-Number: K100327 · 2010-03-22

ApplicantHeartway Medical Products Co., Ltd.
Decision Date2010-03-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEARTWAY POWER CHAIR, P23 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 2010-03-22 under 510(k) number K100327. 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 POWER CHAIR, P23?

HEARTWAY POWER CHAIR, P23 is a medical device that received FDA 510(k) clearance on 2010-03-22. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K100327.

When did HEARTWAY POWER CHAIR, P23 receive FDA 510(k) clearance?

HEARTWAY POWER CHAIR, P23 received FDA 510(k) clearance on 2010-03-22, under 510(k) number K100327.

Who is the listed applicant for HEARTWAY POWER CHAIR, P23?

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 CHAIR, P23?

The FDA product code for HEARTWAY POWER CHAIR, P23 is 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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