The following data is part of a premarket notification filed by Carematix Inc. with the FDA for Carematix Wellness System, Model Cws-5000.1-b.
| Device ID | K100508 |
| 510k Number | K100508 |
| Device Name: | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CAREMATIX INC. 209 W. JACKSON BLVD. SUITE 800 Chicago, IL 60606 |
| Contact | Sukhwant Khanuja |
| Correspondent | Sukhwant Khanuja CAREMATIX INC. 209 W. JACKSON BLVD. SUITE 800 Chicago, IL 60606 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-05-05 |
| Summary: | summary |