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FDA 510(k)

Intimate Rose Kegel Exercise System

K-Number: K193364 · 2020-08-24

ApplicantPlus EV Holdings Dba Intimate Rose
Decision Date2020-08-24
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Intimate Rose Kegel Exercise System is a medical device manufactured by Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2020-08-24 under approval number K193364. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intimate Rose Kegel Exercise System?

Intimate Rose Kegel Exercise System is a medical device that received FDA 510(k) clearance on 2020-08-24. It is manufactured by Plus EV Holdings Dba Intimate Rose. The 510(k) number is K193364.

When was Intimate Rose Kegel Exercise System approved by the FDA?

Intimate Rose Kegel Exercise System received FDA 510(k) clearance on 2020-08-24, under approval number K193364.

What company makes Intimate Rose Kegel Exercise System?

Intimate Rose Kegel Exercise System is manufactured by Plus EV Holdings Dba Intimate Rose.

What is the FDA product code for Intimate Rose Kegel Exercise System?

The FDA product code for Intimate Rose Kegel Exercise System is HIR.

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Other Devices by Plus EV Holdings Dba Intimate Rose

K231430Intimate Rose Vaginal Dilators K241748Intimate Rose Vaginal Dilators

Related Devices (Code: HIR)

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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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