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FDA 510(k)

}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR

K-Number: K850167 · 1985-04-09

ApplicantUrologics, Inc.
Decision Date1985-04-09
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Urologics, Inc.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K850167. 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 }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR?

}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Urologics, Inc.. The 510(k) number is K850167.

When did }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR receive FDA 510(k) clearance?

}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR received FDA 510(k) clearance on 1985-04-09, under 510(k) number K850167.

Who is the listed applicant for }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR?

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

What is the FDA product code for }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR?

The FDA product code for }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR is KPI.

Related Clinical Trials

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Other records listing Urologics, Inc. 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.

K854539UROSTAT

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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