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FDA 510(k)

UROSTYM BIOFEEDBACK AND STIMULATION PROBES

K-Number: K990041 · 1999-08-05

ApplicantLaborie Medical Tech Corp.
Decision Date1999-08-05
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSTYM BIOFEEDBACK AND STIMULATION PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Tech Corp.. It received FDA 510(k) clearance on 1999-08-05 under 510(k) number K990041. 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 UROSTYM BIOFEEDBACK AND STIMULATION PROBES?

UROSTYM BIOFEEDBACK AND STIMULATION PROBES is a medical device that received FDA 510(k) clearance on 1999-08-05. The listed applicant is Laborie Medical Tech Corp.. The 510(k) number is K990041.

When did UROSTYM BIOFEEDBACK AND STIMULATION PROBES receive FDA 510(k) clearance?

UROSTYM BIOFEEDBACK AND STIMULATION PROBES received FDA 510(k) clearance on 1999-08-05, under 510(k) number K990041.

Who is the listed applicant for UROSTYM BIOFEEDBACK AND STIMULATION PROBES?

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

What is the FDA product code for UROSTYM BIOFEEDBACK AND STIMULATION PROBES?

The FDA product code for UROSTYM BIOFEEDBACK AND STIMULATION PROBES is KPI.

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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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Other records listing Laborie Medical Tech Corp. 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.

K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESK991479VISER PENILE TUMESCENCE MONITORK963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMK950016CART, MODE NUMBER UDS-CART

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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