The following data is part of a premarket notification filed by Philips Consumer Lifestyle with the FDA for Pulserelief.
| Device ID | K151035 |
| 510k Number | K151035 |
| Device Name: | PulseRelief |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford, CT 06905 |
| Contact | Marta Walker |
| Correspondent | Marta Walker PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford, CT 06905 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-17 |
| Decision Date | 2015-07-21 |
| Summary: | summary |