Prolong Vibrator
by Ergon Medical, Ltd. 510(k)
Active
510(k) DEN130047
Overview
The Prolong Vibrator is a Class II medical device classified under the FDA’s regulation number 876.5025 as a Vibrator for Climax Control of Premature Ejaculation. It is designed to assist males experiencing premature ejaculation by providing controlled stimulation to extend ejaculatory latency as part of a structured climax control programme. The device operates via external, non-invasive vibration to help users achieve greater control during sexual activity. Its primary function aligns with the FDA’s advisory committee categorisation under Gastroenterology and Urology, though its clinical application remains focused on urological indications.
The Prolong Vibrator is supplied as a single-use or reusable device, though specifications do not explicitly state sterility requirements. It is intended for use in clinical or home settings under medical supervision or patient-directed therapy, adhering to FDA-cleared protocols (K-number: DEN130047). The device is available in multiple registration variants (registration numbers: 3026270764; 3033790325; 3016159407; 3012639861; 3017552081) and is classified under product code PIA. Storage conditions and MRI safety are not detailed in the regulatory data, but compliance with FDA 510(k) clearance (Direct Review, Decision Code: DENG) ensures adherence to safety and performance standards for its intended use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN130047 | Date20 Mar 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA De Novo Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Prolong
- 510(k) Number
- FDA Product Code
- PIA
- FDA applicant
- Ergon Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5025
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- DENG De Novo granted
Questions
What is the Prolong Vibrator designed to treat?
The Prolong Vibrator is a Class II medical device FDA-cleared under regulation 876.5025 as a vibrator for climax control of premature ejaculation. It is specifically intended to assist males experiencing this condition by providing external, non-invasive vibration to extend ejaculatory latency as part of a structured therapy program. The device’s design aligns with FDA advisory committee categorization under urology, though its clinical focus remains on urological indications.
Is the Prolong Vibrator single-use or reusable?
The Prolong Vibrator is available in both single-use and reusable variants, though the regulatory data does not explicitly specify sterility requirements for either version. Users should follow FDA-cleared protocols (K-number: DEN130047) and adhere to proper hygiene practices, especially if the reusable version is shared or used in clinical settings.
How many registration variants of the Prolong Vibrator exist?
The Prolong Vibrator is available in five distinct registration variants, identified by the following FEI numbers: 3026270764, 3033790325, 3016159407, 3012639861, and 3017552081. These variants may differ in specifications or intended use, though the regulatory data does not detail these distinctions. Always verify the correct variant for your specific application.
Where can the Prolong Vibrator be used?
The Prolong Vibrator is intended for use in both clinical and home settings under medical supervision or patient-directed therapy. It adheres to FDA-cleared protocols (K-number: DEN130047) and is designed for structured climax control programs aimed at managing premature ejaculation. Proper training and adherence to manufacturer guidelines are essential for safe and effective use.
What storage conditions should be followed for the Prolong Vibrator?
The regulatory data does not explicitly outline storage conditions or MRI safety for the Prolong Vibrator. However, compliance with FDA 510(k) clearance (Direct Review, Decision Code: DENG) ensures the device meets safety and performance standards for its intended use. Users should follow general medical device storage guidelines, such as protecting the device from extreme temperatures, moisture, and physical damage, unless manufacturer-specific instructions are provided.