| Primary Device ID | B786SBM1AF1100 |
| NIH Device Record Key | 2596f0ee-9712-432f-89af-1b7582c76ee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | actiTENS |
| Version Model Number | Charging case |
| Catalog Number | SBM1AF110 |
| Company DUNS | 267525498 |
| Company Name | SUBLIMED |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B786SBM1AF1100 [Primary] |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| B786SBM2AA2100 | actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana |
| B786SBM2AA1100 | actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana |
| B786SBM1AF1100 | The charging case ensures the charging of the actiTENS Electric impulse generator. |
| B786SBM1AB0110 | The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhes |
| B786SBM1AA1100 | actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana |
| B786SBM1AA0170 | actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana |