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FDA 510(k)

POWER RECLINER

K-Number: K944423 · 1994-11-28

ApplicantSunrise Medical, Inc.
Decision Date1994-11-28
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

POWER RECLINER is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical, Inc.. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K944423. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POWER RECLINER?

POWER RECLINER is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Sunrise Medical, Inc.. The 510(k) number is K944423.

When did POWER RECLINER receive FDA 510(k) clearance?

POWER RECLINER received FDA 510(k) clearance on 1994-11-28, under 510(k) number K944423.

Who is the listed applicant for POWER RECLINER?

The FDA 510(k) record lists Sunrise Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWER RECLINER?

The FDA product code for POWER RECLINER is ITI.

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Other records listing Sunrise Medical, Inc. 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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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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