K974173 is an FDA 510(k) clearance for the ERECAID SYSTEM/STAY EREC SYSTEM. This device is classified as a Device, External Penile Rigidity (Class II - Special Controls, product code LKY).
Submitted by Imagyn Medical Technologies, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 25, 1998, 112 days after receiving the submission on November 5, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5020. Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices..
| 510(k) Number | K974173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1997 |
| Decision Date | February 25, 1998 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKY — Device, External Penile Rigidity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5020 |
| Definition | Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices. |