eCFR Reference Browser

---

title: "21 CFR §876.2040"

source: "https://www.ecfr.gov/current/title-21/section-876.2040"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "876"

part_subject: "GASTROENTEROLOGY-UROLOGY DEVICES"

subpart_code: "C"

subpart_subject: "Monitoring Devices"

section_number: "876.2040"

section_subject: "Enuresis alarm."

cfr_reference: "21 CFR 876.2040"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

§876.2040 - Enuresis alarm.