The following data is part of a premarket notification filed by Sleep Modus, Inc. with the FDA for Actispec Activity Monitor.
| Device ID | K143512 |
| 510k Number | K143512 |
| Device Name: | ActiSpec Activity Monitor |
| Classification | Exerciser, Measuring |
| Applicant | SLEEP MODUS, INC. 1201 RICHARDSON DRIVE, SUITE 280-B Richardson, TX 75080 |
| Contact | Stanford P Hudson |
| Correspondent | Diane Rutherford KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 -4403 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-11 |
| Decision Date | 2015-08-26 |
| Summary: | summary |