The following data is part of a premarket notification filed by Henley Intl. with the FDA for Omega T200.
| Device ID | K870667 |
| 510k Number | K870667 |
| Device Name: | OMEGA T200 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Peter M Graham |
| Correspondent | Peter M Graham HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-19 |
| Decision Date | 1987-04-22 |