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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 the device name listed in this FDA 510(k) record. The listed applicant is Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2020-08-24 under 510(k) 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. The listed applicant is Plus EV Holdings Dba Intimate Rose. The 510(k) number is K193364.

When did Intimate Rose Kegel Exercise System receive FDA 510(k) clearance?

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

Who is the listed applicant for Intimate Rose Kegel Exercise System?

The FDA 510(k) record lists Plus EV Holdings Dba Intimate Rose as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Plus EV Holdings Dba Intimate Rose 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.

K241748Intimate Rose Vaginal DilatorsK231430Intimate Rose Vaginal Dilators

Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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