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FDA 510(k)

Pelvifine Pelvic Muscle Trainer

K-Number: K163288 · 2018-01-18

Decision Date2018-01-18
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvifine Pelvic Muscle Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K163288. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pelvifine Pelvic Muscle Trainer?

Pelvifine Pelvic Muscle Trainer is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K163288.

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

Pelvifine Pelvic Muscle Trainer received FDA 510(k) clearance on 2018-01-18, under 510(k) number K163288.

Who is the listed applicant for Pelvifine Pelvic Muscle Trainer?

The FDA 510(k) record lists Shenzhen Konmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvifine Pelvic Muscle Trainer?

The FDA product code for Pelvifine Pelvic Muscle Trainer is KPI.

Related Clinical Trials

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.

Other records listing Shenzhen Konmed Technology Co., Ltd. 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.

View all 7 devices →

Related Devices (Code: KPI)

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.

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.