The following data is part of a premarket notification filed by Lifecare Ltd. with the FDA for Lifecare Compact Tens Device.
| Device ID | K003369 |
| 510k Number | K003369 |
| Device Name: | LIFECARE COMPACT TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LIFECARE LTD. BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST., Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein LIFECARE LTD. BEIT HAPA'AMON (BOX 124) 20 HATA'AS ST., Kfar Saba, IL 44425 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-30 |
| Decision Date | 2001-03-08 |