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FDA 510(k)

JAZZY ELITE 6

K-Number: K113488 · 2012-04-18

ApplicantPride Mobility Product Corporration
Decision Date2012-04-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

JAZZY ELITE 6 is the device name listed in this FDA 510(k) record. The listed applicant is Pride Mobility Product Corporration. It received FDA 510(k) clearance on 2012-04-18 under 510(k) number K113488. 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 ELITE 6?

JAZZY ELITE 6 is a medical device that received FDA 510(k) clearance on 2012-04-18. The listed applicant is Pride Mobility Product Corporration. The 510(k) number is K113488.

When did JAZZY ELITE 6 receive FDA 510(k) clearance?

JAZZY ELITE 6 received FDA 510(k) clearance on 2012-04-18, under 510(k) number K113488.

Who is the listed applicant for JAZZY ELITE 6?

The FDA 510(k) record lists Pride Mobility Product Corporration as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZY ELITE 6?

The FDA product code for JAZZY ELITE 6 is ITI.

Related Clinical Trials

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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Other records listing Pride Mobility Product Corporration 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.

K112815QUANTUM BARIATRIC 451

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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