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 |