(139 days)
The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Reliant Charger (RC-1)" and its "Indications for Use." This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device was approved based on its substantial equivalence to a predicate device already on the market, not necessarily through a new study demonstrating its efficacy against specific acceptance criteria. The 510(k) process often relies on comparison to existing legally marketed devices rather than requiring de novo clinical trials with predefined acceptance criteria.
Therefore, I cannot provide the requested information for the Reliant Charger (RC-1) based solely on these documents. The information requested (acceptance criteria, performance data, study details, expert qualifications, etc.) is typically found in a clinical study report or a more detailed technical submission, not in the FDA's regulatory approval letter itself.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.