The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Ez Stim.
| Device ID | K954505 |
| 510k Number | K954505 |
| Device Name: | EZ STIM |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | LIFE-TECH INTL., INC. 10920 KINGHURST Houston, TX 77099 |
| Contact | Andrew C Kyle |
| Correspondent | Andrew C Kyle LIFE-TECH INTL., INC. 10920 KINGHURST Houston, TX 77099 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1996-12-10 |