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FDA 510(k)

QUICKIE RHYTHM

K-Number: K083249 · 2008-12-23

ApplicantSunrise Medical Hhg, Inc.
Decision Date2008-12-23
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

QUICKIE RHYTHM is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083249. 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 QUICKIE RHYTHM?

QUICKIE RHYTHM is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K083249.

When did QUICKIE RHYTHM receive FDA 510(k) clearance?

QUICKIE RHYTHM received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083249.

Who is the listed applicant for QUICKIE RHYTHM?

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

What is the FDA product code for QUICKIE RHYTHM?

The FDA product code for QUICKIE RHYTHM is ITI.

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Other records listing Sunrise Medical Hhg, 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.

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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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