The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Healthepod.
| Device ID | K083174 | 
| 510k Number | K083174 | 
| Device Name: | HEALTHEPOD | 
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone | 
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 | 
| Contact | Alex Gonorovsky | 
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 | 
| Product Code | DXH | 
| CFR Regulation Number | 870.2920 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2008-10-27 | 
| Decision Date | 2009-12-17 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HEALTHEPOD  78705087  3779546 Dead/Cancelled | LIFEWATCH AG 2005-09-01 |