The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Transcutaneous Electrical Nerve Stimulators (tens).
| Device ID | K150043 |
| 510k Number | K150043 |
| Device Name: | Transcutaneous Electrical Nerve Stimulators (TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | ANDON HEALTH CO.,LTD NO 3, JIN PING STREET NANKAI DISTRICT Tianjin, CN |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 3, JIN PING STREET NANKAI DISTRICT Tianjin, CN |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-09 |
| Decision Date | 2015-08-14 |
| Summary: | summary |