The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Low-frequency Therapy Instrument /model: Ktr-201, Ktr-202, Ktr-203.
| Device ID | K170205 |
| 510k Number | K170205 |
| Device Name: | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 |
| 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 City, CN 518115 |
| Contact | Zewu Zhang |
| Correspondent | Tracy Che Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District Shenzhen City, CN 518115 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818323021858 | K170205 | 000 |
| 06970651383224 | K170205 | 000 |
| 00859811008510 | K170205 | 000 |
| 06924607700535 | K170205 | 000 |
| 06924607700580 | K170205 | 000 |
| 06924607700603 | K170205 | 000 |
| 06924607700696 | K170205 | 000 |
| 00859811007407 | K170205 | 000 |
| 00860074002207 | K170205 | 000 |
| 00850033118124 | K170205 | 000 |