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FDA 510(k)

INNOVA PELVIC FLOOR STIMULATION SYSTEM

K-Number: K941911 · 1995-01-20

ApplicantEmpi
Decision Date1995-01-20
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVA PELVIC FLOOR STIMULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K941911. 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 INNOVA PELVIC FLOOR STIMULATION SYSTEM?

INNOVA PELVIC FLOOR STIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Empi. The 510(k) number is K941911.

When did INNOVA PELVIC FLOOR STIMULATION SYSTEM receive FDA 510(k) clearance?

INNOVA PELVIC FLOOR STIMULATION SYSTEM received FDA 510(k) clearance on 1995-01-20, under 510(k) number K941911.

Who is the listed applicant for INNOVA PELVIC FLOOR STIMULATION SYSTEM?

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

What is the FDA product code for INNOVA PELVIC FLOOR STIMULATION SYSTEM?

The FDA product code for INNOVA PELVIC FLOOR STIMULATION SYSTEM is KPI.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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