The following data is part of a premarket notification filed by Quantum Devices, Inc. with the FDA for Warp10,warp75.
| Device ID | K113231 |
| 510k Number | K113231 |
| Device Name: | WARP10,WARP75 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | QUANTUM DEVICES, INC. 1920 ARLINGTON PL. Medison, WI 53726 |
| Contact | Morris Waxler |
| Correspondent | Morris Waxler QUANTUM DEVICES, INC. 1920 ARLINGTON PL. Medison, WI 53726 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2012-02-27 |
| Summary: | summary |