The following data is part of a premarket notification filed by Escada International, Inc. with the FDA for Tq Solo And Solo Pro And Ls50 Accessory And Mr4 Multi Radiance Therapy System.
| Device ID | K080102 |
| 510k Number | K080102 |
| Device Name: | TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM |
| 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 |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852556007220 | K080102 | 000 |
| 00852556007022 | K080102 | 000 |
| 00852556007046 | K080102 | 000 |
| 00852556007053 | K080102 | 000 |
| 00852556007060 | K080102 | 000 |
| 00852556007077 | K080102 | 000 |
| 00852556007091 | K080102 | 000 |
| 00852556007107 | K080102 | 000 |
| 00852556007152 | K080102 | 000 |
| 00852556007176 | K080102 | 000 |
| 00852556007183 | K080102 | 000 |
| 00852556007190 | K080102 | 000 |
| 00852556007206 | K080102 | 000 |
| 00852556007015 | K080102 | 000 |