The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Maxpower Relief.
| Device ID | K182120 |
| 510k Number | K182120 |
| Device Name: | Maxpower Relief |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 |
| Contact | Renee Thornborough |
| Correspondent | Paul Dryden Omron Healthcare, Inc. C/o ProMedic, LLC. 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796635005 | K182120 | 000 |