The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Focus Tens Therapy, Model Pm710-m/-l.
| Device ID | K183215 |
| 510k Number | K183215 |
| Device Name: | Focus TENS Therapy, Model PM710-M/-L |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Omron Healthcare, Inc. 1925 West Field Court, Suite 100 Lake Forest, IL 60045 |
| Contact | Renee Thornborough |
| Correspondent | Ronald S. Warren Experien Group 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796637139 | K183215 | 000 |
| 00073796637125 | K183215 | 000 |
| 02007379663162 | K183215 | 000 |
| 20073796124438 | K183215 | 000 |
| 20073796124421 | K183215 | 000 |