Heat Pain Pro
Stimulator, Nerve, Transcutaneous, Over-the-counter
Omron Healthcare, Inc.
The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Heat Pain Pro.
Pre-market Notification Details
| Device ID | K181992 |
| 510k Number | K181992 |
| Device Name: | Heat Pain Pro |
| 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 | 2018-07-26 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796634008 | K181992 | 000 |
| 10073796638006 | K181992 | 000 |
| 20073796752310 | K181992 | 000 |
| 10073796800311 | K181992 | 000 |
Trademark Results [Heat Pain Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEAT PAIN PRO 87065114 5287385 Live/Registered |
Omron Healthcare, Inc. 2016-06-08 |
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