The following data is part of a premarket notification filed by Advanced Warming Systems, Inc. with the FDA for Warmtouch.
| Device ID | K913016 |
| 510k Number | K913016 |
| Device Name: | WARMTOUCH |
| Classification | System, Thermal Regulating |
| Applicant | ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Contact | Patrick J Griffin |
| Correspondent | Patrick J Griffin ADVANCED WARMING SYSTEMS, INC. 3414 22ND ST. Lubbock, TX 79410 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1991-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521063198 | K913016 | 000 |
| 10884521061804 | K913016 | 000 |
| 10884521061798 | K913016 | 000 |
| 10884521061514 | K913016 | 000 |
| 30884521061365 | K913016 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WARMTOUCH 87001708 5086442 Live/Registered |
QINGDAO BANGTE FIBRE CO., LTD. 2016-04-15 |
![]() WARMTOUCH 77739384 3815571 Dead/Cancelled |
AOPEN INCORPORATED 2009-05-18 |
![]() WARMTOUCH 76282919 not registered Dead/Abandoned |
ESTEE LAUDER INC. 2001-07-10 |
![]() WARMTOUCH 74359557 1797714 Dead/Cancelled |
DK HEATING SYSTEMS, LTD. 1993-02-16 |
![]() WARMTOUCH 74179565 1775805 Live/Registered |
COVIDIEN LP 1991-06-25 |