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FDA 510(k)

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)

K-Number: K160031 · 2016-07-14

ApplicantSunrise Medical (Us), LLC
Decision Date2016-07-14
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical (Us), LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160031. 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 Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Sunrise Medical (Us), LLC. The 510(k) number is K160031.

When did Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) receive FDA 510(k) clearance?

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160031.

Who is the listed applicant for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

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

What is the FDA product code for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

The FDA product code for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is ITI.

Other records listing Sunrise Medical (Us), LLC 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.

K220213Empulse R90K172384Quickie(r) Q700-UP M

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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