Last synced on 27 January 2023 at 11:04 pm

Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5310
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5310 Nonimplanted, peripheral electrical continence device

§ 876.5310 Nonimplanted, peripheral electrical continence device.

(a) Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.

(b) Classification. Class II, subject to the following special controls:

(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]

Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5310
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5310 Nonimplanted, peripheral electrical continence device

§ 876.5310 Nonimplanted, peripheral electrical continence device.

(a) Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.

(b) Classification. Class II, subject to the following special controls:

(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]