The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Pro Tens, Model Wl-240 Rx.
| Device ID | K080304 |
| 510k Number | K080304 |
| Device Name: | PRO TENS, MODEL WL-240 RX |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-05 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872264088 | K080304 | 000 |