The following data is part of a premarket notification filed by Medx Electronics, Inc. with the FDA for Medx Home.
| Device ID | K050022 |
| 510k Number | K050022 |
| Device Name: | MEDX HOME |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDX ELECTRONICS, INC. 3350 RIDGEWAY DRIVE UNIT 3 Mississauga On, CA L5l 5z9 |
| Contact | Anita Saltmarche |
| Correspondent | Anita Saltmarche MEDX ELECTRONICS, INC. 3350 RIDGEWAY DRIVE UNIT 3 Mississauga On, CA L5l 5z9 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-05 |
| Decision Date | 2005-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628451918332 | K050022 | 000 |
| 00628451918165 | K050022 | 000 |
| 00628451918189 | K050022 | 000 |