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FDA 510(k)

Pelvital System

K-Number: K200409 · 2020-07-10

ApplicantPelvital USA, Inc.
Decision Date2020-07-10
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pelvital System is the device name listed in this FDA 510(k) record. The listed applicant is Pelvital USA, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K200409. 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 Pelvital System?

Pelvital System is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Pelvital USA, Inc.. The 510(k) number is K200409.

When did Pelvital System receive FDA 510(k) clearance?

Pelvital System received FDA 510(k) clearance on 2020-07-10, under 510(k) number K200409.

Who is the listed applicant for Pelvital System?

The FDA 510(k) record lists Pelvital USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvital System?

The FDA product code for Pelvital System is HIR.

Other records listing Pelvital USA, Inc. 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.

K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)K212655FlyteK210764Flyte

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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