The following data is part of a premarket notification filed by Medica Health, Ltd with the FDA for Theragem Professional T1002.
| Device ID | K081505 |
| 510k Number | K081505 |
| Device Name: | THERAGEM PROFESSIONAL T1002 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDICA HEALTH, LTD 2842 KELLY BROOKE LANE Deerfield Beach, FL 33442 |
| Contact | Terri Cmorey |
| Correspondent | Terri Cmorey MEDICA HEALTH, LTD 2842 KELLY BROOKE LANE Deerfield Beach, FL 33442 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-11-19 |
| Summary: | summary |