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FDA 510(k)

INCONTROL

K-Number: K110179 · 2012-02-22

ApplicantIncontrol Medical, LLC
Decision Date2012-02-22
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INCONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Incontrol Medical, LLC. It received FDA 510(k) clearance on 2012-02-22 under 510(k) number K110179. 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 INCONTROL?

INCONTROL is a medical device that received FDA 510(k) clearance on 2012-02-22. The listed applicant is Incontrol Medical, LLC. The 510(k) number is K110179.

When did INCONTROL receive FDA 510(k) clearance?

INCONTROL received FDA 510(k) clearance on 2012-02-22, under 510(k) number K110179.

Who is the listed applicant for INCONTROL?

The FDA 510(k) record lists Incontrol Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCONTROL?

The FDA product code for INCONTROL is KPI.

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Other records listing Incontrol Medical, LLC 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.

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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.

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag

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.

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