| Primary Device ID | 00041167080498 |
| NIH Device Record Key | 17a53f67-d949-4312-9e8a-9dcd2749f879 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Icy Hot SmartRelief |
| Version Model Number | SmartRelief 1.0 - Knee/Shoulder Refill |
| Company DUNS | 003336013 |
| Company Name | CHATTEM, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00041167080498 [Primary] |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-02-19 |
| Device Publish Date | 2016-08-25 |
| 00041167080818 | Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back |
| 00041167080498 | Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder ref |
| 00041167080474 | Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder |
| 00041167080467 | Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back and Hip refill e |
| 00041167080450 | Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip |