The following data is part of a premarket notification filed by Nice Recovery Systems, Llc with the FDA for Nice1.
| Device ID | K143197 | 
| 510k Number | K143197 | 
| Device Name: | Nice1 | 
| Classification | Massager, Powered Inflatable Tube | 
| Applicant | NICE RECOVERY SYSTEMS, LLC 1382 KALMIA AVE, Boulder, CO 80304 | 
| Contact | Michael Ross | 
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 | 
| Product Code | IRP | 
| CFR Regulation Number | 890.5650 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | Yes | 
| Combination Product | No | 
| Date Received | 2014-11-06 | 
| Decision Date | 2014-12-23 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00862103000307 | K143197 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  NICE1  98220556  not registered Live/Pending | Nice Recovery Systems LLC 2023-10-12 | 
|  NICE1  86904410  not registered Dead/Abandoned | Nice Recovery Systems LLC 2016-02-11 |