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FDA 510(k)

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM

K-Number: K093600 · 2009-12-04

ApplicantAccelerated Care Plus
Decision Date2009-12-04
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Care Plus. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K093600. 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 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM?

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Accelerated Care Plus. The 510(k) number is K093600.

When did OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM receive FDA 510(k) clearance?

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM received FDA 510(k) clearance on 2009-12-04, under 510(k) number K093600.

Who is the listed applicant for OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM?

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

What is the FDA product code for OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM?

The FDA product code for OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM is KPI.

Related Clinical Trials

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Other records listing Accelerated Care Plus 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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