The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Hilthera 4.0.
| Device ID | K141861 |
| 510k Number | K141861 |
| Device Name: | HILTHERA 4.0 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | JEISYS MEDICAL, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung JEISYS MEDICAL, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-10 |
| Decision Date | 2015-01-07 |
| Summary: | summary |