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Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Page Type
Product Code
Definition
A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
Physical State
Electrode(s) designed to stimulate perineal muscles and nerves.
Technical Method
Electrical stimulation of perineal muscles and nerves.
Target Area
Perineal muscles and nerves.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5026
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation

§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.

(a) Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Mechanical performance;

(ii) Electrical stimulation parameters; and

(iii) Battery performance.

(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) Specific instructions regarding safe placement and correct use of the device;

(ii) Warning(s) against use by patients with active implanted medical devices; and

(iii) A shelf life.

[87 FR 34166, Apr. 5, 2022]

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Page Type
Product Code
Definition
A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
Physical State
Electrode(s) designed to stimulate perineal muscles and nerves.
Technical Method
Electrical stimulation of perineal muscles and nerves.
Target Area
Perineal muscles and nerves.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5026
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation

§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.

(a) Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Mechanical performance;

(ii) Electrical stimulation parameters; and

(iii) Battery performance.

(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) Specific instructions regarding safe placement and correct use of the device;

(ii) Warning(s) against use by patients with active implanted medical devices; and

(iii) A shelf life.

[87 FR 34166, Apr. 5, 2022]