The following data is part of a premarket notification filed by Chattem, Inc. with the FDA for Smartrelief.
Device ID | K131159 |
510k Number | K131159 |
Device Name: | SMARTRELIEF |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | CHATTEM, INC. 1715 WEST 38TH ST. Chattanooga, TN 37409 |
Contact | Eric Joseph |
Correspondent | Eric Joseph CHATTEM, INC. 1715 WEST 38TH ST. Chattanooga, TN 37409 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-24 |
Decision Date | 2013-07-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00041167080818 | K131159 | 000 |
00041167080498 | K131159 | 000 |
00041167080474 | K131159 | 000 |
00041167080467 | K131159 | 000 |
00041167080450 | K131159 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMARTRELIEF 97614496 not registered Live/Pending |
E & E CO., LTD. 2022-09-30 |
SMARTRELIEF 85072755 not registered Dead/Abandoned |
NuPathe Inc. 2010-06-28 |
SMARTRELIEF 78857641 not registered Dead/Abandoned |
NuPathe Inc. 2006-04-10 |