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Model 1750 Standing Urinal

by Life-Tech Instruments, Inc.

510(k) K790663

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790663 Date24 Apr 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFG
Device Class
Class II
Regulation
21 CFR Part 876.1800
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 1750 Standing Urinal is a non-electrical, disposable device used for measuring urine flow rate. It is classified as a medical device under regulation number 876.1800.

This device is identified by K-number K790663 and has received FDA 510(k) clearance. It is intended for use within the fields of gastroenterology and urology.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Model 1750 Standing Urinal?

    The Model 1750 Standing Urinal is specifically designed for measuring urine flow rate. It is intended for clinical use within the fields of urology and gastroenterology.

  • Is the Model 1750 Standing Urinal intended for single-use or reuse?

    The device is classified as a disposable medical device. This means it is intended for single-use to ensure hygiene and accuracy during the measurement of urine flow rate.

  • Does this device require an electrical power source?

    No, the Model 1750 Standing Urinal is a non-electrical device. It functions without the need for external power, making it a straightforward tool for clinical flow rate measurements.

  • What is the regulatory status of this device?

    The Model 1750 Standing Urinal has received FDA 510(k) clearance under K-number K790663. It is classified as a medical device under regulation number 876.1800.