| Primary Device ID | 24712832961014 |
| NIH Device Record Key | 0df584df-da1a-455a-9994-f6d6000f74fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM-STIM |
| Version Model Number | GM3A40TE |
| Catalog Number | GM3A40TE |
| Company DUNS | 658435078 |
| Company Name | GEMORE TECHNOLOGY CO., LTD. |
| 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 |
|---|---|
| GS1 | 04712832961010 [Primary] |
| GS1 | 24712832961014 [Package] Contains: 04712832961010 Package: Carton [30 Units] In Commercial Distribution |
| IPF | Stimulator, Muscle, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
| 04712832960396 | GM320PE Bottom System |
| 04712832960389 | GM3A10T Analog TENS |
| 04712832960372 | GM320T Digital TENS |
| 04712832960365 | GM320TE Digital Combo TENS+EMS |
| 04712832960358 | GM3A10T Analog TENS |
| 04712832960341 | OMNI GM3A50T Analog TENS with protective cover |
| 04712832960334 | Butterfly Electrode |
| 04712832960327 | Electrode Pad 40x40mm |
| 04712832960303 | GM3A10E Analog EMS |
| 04712832960297 | GM320E(C) Digital EMS |
| 04712832960280 | GM3A10T(0) Analog TENS |
| 04712832960273 | GM3A50E Analog EMS |
| 04712832960266 | GM3A50T Analog TENS |
| 04712832960259 | GM3A50T(0) Analog TENS |
| 04712832960242 | Analog TENS |
| 04712832960235 | Digital Combo TENS+EMS |
| 04712832960228 | Digital TENS |
| 04712832960204 | Digital Pre-program TENS |
| 04712832960198 | Digital Pre-program EMS |
| 04712832960075 | Electrode Pad 50x50mm |
| 04712832960068 | Electrode Pad 40x40mm |
| 04712832960051 | Lead Wire |
| 04712832960044 | High Voltage Pulsed Galvanic Stimulator |
| 04712832960037 | Digital TENS |
| 04712832960020 | Analog Combo (TENS+EMS) |
| 04712832960013 | Powered muscle stimulator, Analog EMS |
| 04712832960006 | Physiotherapy Stimulator Analog TENS |
| 04712832960426 | GM3A20T Analog TENS |
| 04712832960082 | Electrode Pad 45mm |
| 24712832961489 | OTC TENS |
| 24712832961366 | Digital TENS |
| 24712832961144 | Clinical type TENS |
| 24712832960536 | Clinical type EMS |
| 24712832960529 | Digital Combo TENS+EMS+IF |
| 24712832960505 | Digital Combo TENS+EMS |
| 24712832960499 | Digital EMS |
| 24712832960482 | Digital TENS |
| 24712832960475 | Analog Interferential |
| 04712832960419 | Digital EMS |
| 04712832960211 | GM322IF Interferential |
| 24712832960512 | Pre-program TENS |
| 24712832961083 | Interferential Stimulator |
| 04712832961072 | Interferential Stimulator |
| 04712832961065 | Interferential Stimulator |
| 04712832961058 | Interferential Stimulator |
| 24712832961045 | Interferential Stimulator |
| 24712832961014 | Analog Combo (TENS+EMS) |
| 24712832960987 | Analog EMS |
| 24712832960970 | Analog TENS |
| 24712832960963 | Analog Combo (TENS+EMS) |