The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Transcutaneous Electrical Nerve Stimulator.
| Device ID | K183288 |
| 510k Number | K183288 |
| Device Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District Shenzhen, CN 518115 |
| Contact | Zewu Zhang |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, CN 518000 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06924607701624 | K183288 | 000 |
| 06924607701617 | K183288 | 000 |
| 06924607701600 | K183288 | 000 |
| 00850033118117 | K183288 | 000 |