The following data is part of a premarket notification filed by Ercona Corp. with the FDA for Ryusei.
| Device ID | K772424 |
| 510k Number | K772424 |
| Device Name: | RYUSEI |
| Classification | Locator, Acupuncture Point |
| Applicant | ERCONA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWJ |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-28 |
| Decision Date | 1978-05-09 |