The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecolotion Transmission And Massage Lotion.
| Device ID | K962840 |
| 510k Number | K962840 |
| Device Name: | ECOLOTION TRANSMISSION AND MASSAGE LOTION |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
| Contact | Paul L Hooey |
| Correspondent | Paul L Hooey ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055650898 | K962840 | 000 |
| 00812433029295 | K962840 | 000 |
| 00628055650812 | K962840 | 000 |
| 00628055650829 | K962840 | 000 |
| 00628055650836 | K962840 | 000 |
| 00628055650843 | K962840 | 000 |
| 00628055650850 | K962840 | 000 |
| 00628055650867 | K962840 | 000 |
| 00628055650874 | K962840 | 000 |
| 00628055650881 | K962840 | 000 |
| M220P3011153 | K962840 | 000 |