FDA 510(k)

Perifit

K-Number: K221476 · 2023-02-10

Decision Date2023-02-10

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Perifit is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K221476. 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?

Perifit is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is X6 Innovations. The 510(k) number is K221476.

When did Perifit receive FDA 510(k) clearance?

Perifit received FDA 510(k) clearance on 2023-02-10, under 510(k) number K221476.

Who is the listed applicant for Perifit?

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?

The FDA product code for Perifit 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 K231780Perifit Care+

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.K231780Perifit Care+X6 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.