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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 a medical device manufactured by Pelvital USA, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval 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. It is manufactured by Pelvital USA, Inc.. The 510(k) number is K200409.

When was Pelvital System approved by the FDA?

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

What company makes Pelvital System?

Pelvital System is manufactured by Pelvital USA, Inc..

What is the FDA product code for Pelvital System?

The FDA product code for Pelvital System is HIR.

Other Devices by Pelvital USA, Inc.

K212655Flyte K210764Flyte K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

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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