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FDA 510(k)

JAZZY

K-Number: K945936 · 1996-05-28

ApplicantPride Health Care, Inc.
Decision Date1996-05-28
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JAZZY is the device name listed in this FDA 510(k) record. The listed applicant is Pride Health Care, Inc.. It received FDA 510(k) clearance on 1996-05-28 under 510(k) number K945936. 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 JAZZY?

JAZZY is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Pride Health Care, Inc.. The 510(k) number is K945936.

When did JAZZY receive FDA 510(k) clearance?

JAZZY received FDA 510(k) clearance on 1996-05-28, under 510(k) number K945936.

Who is the listed applicant for JAZZY?

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

What is the FDA product code for JAZZY?

The FDA product code for JAZZY is ITI.

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Other records listing Pride Health Care, Inc. as applicant

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.

K944940EURO SC500K953342TMR48K944277DYNAMOK944939CELEBRITY XL SC445K931231SIDEKICK IIK930952PRIDE LEGEND SC-340

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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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