Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

K-Number: K011435 · 2001-06-22

ApplicantHmt, Inc.
Decision Date2001-06-22
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hmt, Inc.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011435. 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 HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM?

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Hmt, Inc.. The 510(k) number is K011435.

When did HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM receive FDA 510(k) clearance?

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011435.

Who is the listed applicant for HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM?

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

What is the FDA product code for HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM?

The FDA product code for HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM is KPI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑