The following data is part of a premarket notification filed by Rg Ent., Inc. with the FDA for Geratherm Sos-vacutherm (thermamed Smartcare).
| Device ID | K051278 |
| 510k Number | K051278 |
| Device Name: | GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) |
| Classification | System, Thermal Regulating |
| Applicant | RG ENT., INC. 21130 BRIDGE STREET Southfield, MI 48034 |
| Contact | Ronald G Letourneau |
| Correspondent | Ronald G Letourneau RG ENT., INC. 21130 BRIDGE STREET Southfield, MI 48034 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2006-06-29 |
| Summary: | summary |