FDA 510(k)

Perifit Care+

K-Number: K231780 · 2023-12-20

Decision Date2023-12-20

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Perifit Care+ is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231780. 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 Perifit Care+?

Perifit Care+ is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is X6 Innovations. The 510(k) number is K231780.

When did Perifit Care+ receive FDA 510(k) clearance?

Perifit Care+ received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231780.

Who is the listed applicant for Perifit Care+?

The FDA 510(k) record lists X6 Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perifit Care+?

The FDA product code for Perifit Care+ is HIR.

Other records listing X6 Innovations 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.

K231785Perifit Pump K221476Perifit

Related Devices (Code: HIR)

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.K221476PerifitX6 Innovations K213913leva Pelvic Health SystemRenovia, Inc.

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.