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FDA 510(k)

Empulse R90

K-Number: K220213 · 2022-03-30

ApplicantSunrise Medical (Us), LLC
Decision Date2022-03-30
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Empulse R90 is a medical device manufactured by Sunrise Medical (Us), LLC. It received FDA 510(k) clearance on 2022-03-30 under approval number K220213. 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 Empulse R90?

Empulse R90 is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Sunrise Medical (Us), LLC. The 510(k) number is K220213.

When was Empulse R90 approved by the FDA?

Empulse R90 received FDA 510(k) clearance on 2022-03-30, under approval number K220213.

What company makes Empulse R90?

Empulse R90 is manufactured by Sunrise Medical (Us), LLC.

What is the FDA product code for Empulse R90?

The FDA product code for Empulse R90 is ITI.

Other Devices by Sunrise Medical (Us), LLC

K160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) K172384Quickie(r) Q700-UP M

Related Devices (Code: ITI)

K161241e-fix E35/E36Alber GmbH K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc K160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)Sunrise Medical (Us), LLC K151717twionAlber GmbH K153543WHILL Model MWhill, Inc. K152672Cajun Commando 4x4Lil Critter, LLC

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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