FDA 510(k)

Vibrance Pelvic Trainer

K-Number: K162689 · 2017-06-08

Decision Date2017-06-08

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Vibrance Pelvic Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Bioinfinity (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162689. 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 Vibrance Pelvic Trainer?

Vibrance Pelvic Trainer is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Bioinfinity (M) Sdn. Bhd.. The 510(k) number is K162689.

When did Vibrance Pelvic Trainer receive FDA 510(k) clearance?

Vibrance Pelvic Trainer received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162689.

Who is the listed applicant for Vibrance Pelvic Trainer?

The FDA 510(k) record lists Bioinfinity (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vibrance Pelvic Trainer?

The FDA product code for Vibrance Pelvic Trainer is HIR.

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 Innovations K221476PerifitX6 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.