The following data is part of a premarket notification filed by Henley Intl. with the FDA for Jeltrode.
| Device ID | K861956 |
| 510k Number | K861956 |
| Device Name: | JELTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() JELTRODE 73609685 1486033 Dead/Cancelled |
NEUROMEDICS, INC. 1986-07-14 |