The following data is part of a premarket notification filed by Well-life Healthcare, Inc. with the FDA for Limited Function Wl/otc-tens Device, Model Wl-2103a, Wl-2203a, Wl-2203b And Wl-2401.
| Device ID | K040512 |
| 510k Number | K040512 |
| Device Name: | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE HEALTHCARE, INC. 1109 MYATT BLVD. Madison, TN 37115 |
| Contact | Mike Price |
| Correspondent | Mike Price WELL-LIFE HEALTHCARE, INC. 1109 MYATT BLVD. Madison, TN 37115 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-05-27 |