The following data is part of a premarket notification filed by Bayer Healthcare Llc with the FDA for Aleve Direct Therapy (aleve Direct Therapy Tens Device).
| Device ID | K171802 |
| 510k Number | K171802 |
| Device Name: | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Bayer HealthCare LLC 100 Bayer Boulevard Whippany, NJ 07981 -0915 |
| Contact | Cindy R. Abraham |
| Correspondent | Verna Mecadon Bayer HealthCare LLC 100 Bayer Boulevard Whippany, NJ 07981 -0915 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2018-03-07 |
| Summary: | summary |