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Vibrator For Climax Control Of Premature Ejaculation

Page Type
Product Code
Definition
Vibrator for climax control training for the treatment of premature ejaculation.
Physical State
The device consists of a vibrator connected to a battery pack.
Technical Method
Battery-operated vibrator and lubricant for climax control of premature ejaculation for men
Target Area
Male genitals
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.5025
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5025 Vibrator for climax control of premature ejaculation

§ 876.5025 Vibrator for climax control of premature ejaculation.

(a) Identification. A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

(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 the limitations in § 876.9. The special controls for this device are:

(1) The labeling must include specific instructions regarding the proper placement and use of the device.

(2) The portions of the device that contact the patient must be demonstrated to be biocompatible.

(3) Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.

(4) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

[80 FR 30355, May 28, 2015, as amended at 84 FR 71814, Dec. 30, 2019]

Vibrator For Climax Control Of Premature Ejaculation

Page Type
Product Code
Definition
Vibrator for climax control training for the treatment of premature ejaculation.
Physical State
The device consists of a vibrator connected to a battery pack.
Technical Method
Battery-operated vibrator and lubricant for climax control of premature ejaculation for men
Target Area
Male genitals
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
876.5025
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5025 Vibrator for climax control of premature ejaculation

§ 876.5025 Vibrator for climax control of premature ejaculation.

(a) Identification. A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

(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 the limitations in § 876.9. The special controls for this device are:

(1) The labeling must include specific instructions regarding the proper placement and use of the device.

(2) The portions of the device that contact the patient must be demonstrated to be biocompatible.

(3) Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.

(4) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

[80 FR 30355, May 28, 2015, as amended at 84 FR 71814, Dec. 30, 2019]