The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Tens For Arm And Leg Pain Relief, Model Wl-2407.
| Device ID | K091757 |
| 510k Number | K091757 |
| Device Name: | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW 234 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2010-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682891210197 | K091757 | 000 |
| 00853635002037 | K091757 | 000 |
| B311PEPULSEPRO1 | K091757 | 000 |