The following data is part of a premarket notification filed by Escada International, Inc. with the FDA for Terraquant Mq2000 V.5 With The Tq-1tens.
| Device ID | K071445 |
| 510k Number | K071445 |
| Device Name: | TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ESCADA INTERNATIONAL, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ESCADA INTERNATIONAL, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | ILY |
| Subsequent Product Code | GEX |
| Subsequent Product Code | GZJ |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-24 |
| Decision Date | 2007-10-29 |