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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

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 a medical device manufactured by Sunrise Medical (Us), LLC. It received FDA 510(k) clearance on 2016-07-14 under approval 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. It is manufactured by Sunrise Medical (Us), LLC. The 510(k) number is K160031.

When was Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) approved by the FDA?

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 approval number K160031.

What company makes 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 manufactured by Sunrise Medical (Us), LLC.

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 Devices by Sunrise Medical (Us), LLC

Related Devices (Code: ITI)

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.