The following data is part of a premarket notification filed by Top-rank Health Care Co.,ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator.
| Device ID | K210223 |
| 510k Number | K210223 |
| Device Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Top-Rank Health Care Co.,Ltd. Checun Village, Dongguan St. Shang-Yu District Shaoxing, CN 312352 |
| Contact | James Zhou |
| Correspondent | Yuling Chen Microkn Business Consulting (Shanghai) Co., Ltd. Room 1219, Block A, No3699, Gonghexin Road, Jingan District Shanghai, CN 200040 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-12-15 |