| Primary Device ID | B1870141 |
| NIH Device Record Key | 230b8101-1260-4552-a49d-d1a508a0ab57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraKnit |
| Version Model Number | TKP-1080 |
| Company DUNS | 147018519 |
| Company Name | NEUROTRON MEDICAL, INC. |
| Device Count | 2 |
| 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 | true |
| Serial Number | false |
| 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 | B1870140 [Unit of Use] |
| HIBCC | B1870141 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-08 |
| B1870670 | Conductive pad kit: 2 pc. 3 in. x 4.5 in.; 1 pc. 3 in. x 7 in.; 1 pc. 1.5 in. x 7 in. |
| B1870141 | Conductive pad, 1.5 in. x 8 in., 2/package |
| B1870121 | Conductive pad, 3 in. x 5 in., 2/package |
| B1870111 | Conductive pad, 2 in. x 3 in., 2/package |
| B1870090 | Conductive duo-glove, dual polarity, 1/package |
| B1870070 | Conductive duo-elbow, dual polarity, 1/package |
| B1870060 | Conductive sock, dual polarity, 1/package |
| B1870050 | Conductive knee, single polarity, 1/package |
| B1870020 | Conductive sock, single polarity, 1/package |
| B1870010 | Conductive glove, single polarity, 1/package |
| B1870080 | Conductive duo-knee, dual polarity, 1/package |