| Primary Device ID | 00851640007412 |
| NIH Device Record Key | 089ec501-f71e-49a6-acf5-fd5d02ff3be9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiDow TrueStim |
| Version Model Number | HD-5N-Y |
| Company DUNS | 124034476 |
| Company Name | Hi-Dow International Incorporated |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851640007412 [Primary] |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2017-12-20 |
| 00810093080373 - HiDow | 2024-10-30 Universal Receiver |
| 00810093080205 - MYOPUX | 2024-07-11 MYOPUX Xpansion Pux Black |
| 00810093080045 - HiDow | 2024-05-17 Pro-Touch Wireless 6-12 Black & White |
| 00810093080137 - MYOPUX | 2024-05-17 MYOPUX eDN White |
| 00810093080144 - MYOPUX | 2024-05-17 MYOPUX eDN Xpansion White&Black |
| 00081009308007 - TrueStim | 2023-10-06 Pulsed Electromagnetic Field Wrap, Black, lower limb wrap |
| 00810093080014 - PainPod | 2022-05-24 TENS for pain relief |
| 00851640007672 - HiDow | 2022-05-24 Wrap Accessory Electrode, AcuElbow Wrap |