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 |