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21 C.F.R. · Food and Drugs
21 C.F.R. § 876.5320

Nonimplanted electrical continence device.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 876.5320 — Nonimplanted electrical continence device.

§ 876.5320 Nonimplanted electrical continence device. (a) Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940). (b) Classification. Class II (performance standards).

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-B2134A
Entity Class
REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 876.5320
Corpus
CFR — Code of Federal Regulations
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PRIMARY-SOURCE
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✓ TRUE
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fd80980d991739c8...
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The regulatory text of 21 C.F.R. § 876.5320 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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← 21 C.F.R. § 876.5310 21 C.F.R. § 876.5330 →
Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain ← All Legislation
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boisestandard.org → United States → Law → CFR → Title 21 → 21 C.F.R. § 876.5320