E-Stim II ED3922
GUDID 14897076720030
The E-Stim II® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions.
TENS PLUS INDUSTRIAL COMPANY
Analgesic transcutaneous electrical nerve stimulation system| Primary Device ID | 14897076720030 |
| NIH Device Record Key | 25513770-e2a7-4284-bcda-cd1788ea219a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E-Stim II |
| Version Model Number | ED3922 |
| Catalog Number | ED3922 |
| Company DUNS | 663211978 |
| Company Name | TENS PLUS INDUSTRIAL COMPANY |
| 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 |
Customer Support Contacts
| Phone | 800-722-8775 |
| customerservice@lhasaoms.com | |
| Phone | 800-722-8775 |
| customerservice@lhasaoms.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14897076720030 [Primary] |
| GS1 | 34897076720034 [Package] Package: Master Case [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050435
FDA Product Code
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-08-04 |
Devices Manufactured by TENS PLUS INDUSTRIAL COMPANY
| 14897076721457 - Lion.Warm.XL | 2023-06-13 |
| 14897076721655 - Multi.D.1.5 | 2023-06-13 |
| 14897076721815 - Moxa.Bx.BamS | 2023-06-13 |
| 14897076721822 - Moxa.Bx.BamL | 2023-06-13 |
| 14897076721853 - Pistol | 2023-06-13 |
| 14897076721860 - Pistol.Long | 2023-06-13 |
| 14897076721877 - Ins.MP.S | 2023-06-13 |
| 14897076721884 - Ins.MP.M | 2023-06-13 |
Trademark Results [E-Stim II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-STIM II 76113568 2596280 Live/Registered |
Lhasa OMS, Inc. 2000-08-21 |
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