The following data is part of a premarket notification filed by Easywell Biomedicals, Inc. with the FDA for Easywell Tens System Tens And Heat, Easywell Tens System Tens Only.
| Device ID | K163166 |
| 510k Number | K163166 |
| Device Name: | EASYWELL TENS System TENS And Heat, EASYWELL TENS System TENS Only |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EASYWELL BIOMEDICALS, INC. SUITE 2, 2F, NO.9, JHANYE 1 RD. HSINCHU SCIENCE PARK Hsinchu, TW |
| Contact | Arthur Chen |
| Correspondent | Arthur Chen EASYWELL BIOMEDICALS, INC. SUITE 2, 2F, NO.9, JHANYE 1 RD. HSINCHU SCIENCE PARK Hsinchu, TW |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-08-11 |
| Summary: | summary |