The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for 4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim Iv, Wl-2504a.
| Device ID | K100399 |
| 510k Number | K100399 |
| Device Name: | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A |
| 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 Hseih |
| Correspondent | Jenny Hseih WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682891210104 | K100399 | 000 |
| 00682891210050 | K100399 | 000 |
| 04719872265047 | K100399 | 000 |