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 |