Med4 Elite
Massager, Powered Inflatable Tube
Cool Systems, Inc. (dba Game Ready)
The following data is part of a premarket notification filed by Cool Systems, Inc. (dba Game Ready) with the FDA for Med4 Elite.
Pre-market Notification Details
| Device ID | K171685 |
| 510k Number | K171685 |
| Device Name: | Med4 Elite |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Cool Systems, Inc. (dba Game Ready) 1800 Sutter Street, Suite 500 Concord, CA 94520 |
| Contact | Natalie Kennel |
| Correspondent | Natalie Kennel NJK & Associates 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-07 |
| Decision Date | 2017-09-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812120003188 | K171685 | 000 |
| 00812120002662 | K171685 | 000 |
| 00812120004499 | K171685 | 000 |
| 00812120004451 | K171685 | 000 |
| 00812120004444 | K171685 | 000 |
| 00812120004413 | K171685 | 000 |
| 00812120004383 | K171685 | 000 |
| 00812120004352 | K171685 | 000 |
| 00812120004345 | K171685 | 000 |
| 00812120004338 | K171685 | 000 |
| 00812120004321 | K171685 | 000 |
| 00812120004314 | K171685 | 000 |
| 00812120004307 | K171685 | 000 |
| 00812120004291 | K171685 | 000 |
| 00812120004284 | K171685 | 000 |
| 00812120004260 | K171685 | 000 |
| 00812120004246 | K171685 | 000 |
| 00812120003560 | K171685 | 000 |
| 00812120003591 | K171685 | 000 |
| 00812120003614 | K171685 | 000 |
| 00812120004048 | K171685 | 000 |
| 00812120004031 | K171685 | 000 |
| 00812120003805 | K171685 | 000 |
| 00812120003799 | K171685 | 000 |
| 00812120003768 | K171685 | 000 |
| 00812120003744 | K171685 | 000 |
| 00812120003737 | K171685 | 000 |
| 00812120003706 | K171685 | 000 |
| 00812120003690 | K171685 | 000 |
| 00812120003683 | K171685 | 000 |
| 00812120003676 | K171685 | 000 |
| 00812120003669 | K171685 | 000 |
| 00812120003652 | K171685 | 000 |
| 00812120003645 | K171685 | 000 |
| 00812120003638 | K171685 | 000 |
| 00812120003621 | K171685 | 000 |
| 00812120004208 | K171685 | 000 |
Trademark Results [Med4 Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MED4 ELITE 86688960 5470017 Live/Registered |
CoolSystems, Inc. 2015-07-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.