The following data is part of a premarket notification filed by Brain Cool Ab with the FDA for The Iqooltm Warm System.
| Device ID | K180375 |
| 510k Number | K180375 |
| Device Name: | The IQoolTM Warm System |
| Classification | System, Thermal Regulating |
| Applicant | Brain Cool AB Scheelevägen 2 Medicon Village, SE Se-223 81 |
| Contact | Martin Waleij |
| Correspondent | Adam Harris Target Health Inc 261 Madison Ave New York, NY 10016 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-05-18 |
| Summary: | summary |