The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Meditrode Kit.
| Device ID | K882554 |
| 510k Number | K882554 |
| Device Name: | MEDITRODE KIT |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Coats, Md |
| Correspondent | Coats, Md LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1988-12-23 |