The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Tens For Low Back Pain Relief, Model Wl-2407.
| Device ID | K063660 |
| 510k Number | K063660 |
| Device Name: | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 68 MODY ROAD TSIMSHATSUIM Kowloon, HK |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh WELL-LIFE HEALTHCARE LIMITED 68 MODY ROAD TSIMSHATSUIM Kowloon, HK |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682891210173 | K063660 | 000 |
| 04719872264071 | K063660 | 000 |