The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecogel 300 Tens Gel.
| Device ID | K962681 |
| 510k Number | K962681 |
| Device Name: | ECOGEL 300 TENS GEL |
| Classification | Media, Electroconductive |
| 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 | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-10 |
| Decision Date | 1996-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055650546 | K962681 | 000 |
| 00628055650539 | K962681 | 000 |
| 00628055650522 | K962681 | 000 |
| 00628055650515 | K962681 | 000 |
| 00616784123912 | K962681 | 000 |
| 00616784124018 | K962681 | 000 |