The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Soft-temp.
| Device ID | K921920 |
| 510k Number | K921920 |
| Device Name: | SOFT-TEMP |
| Classification | System, Thermal Regulating |
| Applicant | ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
| Contact | Scott E Gammons |
| Correspondent | Scott E Gammons ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1992-12-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOFT-TEMP 77409995 3532799 Live/Registered |
Adroit Medical Systems, Inc 2008-02-29 |
![]() SOFT-TEMP 74291321 1847297 Dead/Cancelled |
Adroit Medical Systems, Inc. 1992-07-06 |
![]() SOFT-TEMP 74207136 not registered Dead/Abandoned |
Soft-Temp Technologies Ltd. 1991-09-26 |