| Primary Device ID | 08800250280694 |
| NIH Device Record Key | 99eed286-4211-48e1-87d3-c2533539f4eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quadthera |
| Version Model Number | Quadthera-T1 |
| Company DUNS | 694172688 |
| Company Name | ECO DM LAB Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800250280694 [Primary] |
| ISA | Massager, Therapeutic, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-24 |
| Device Publish Date | 2026-02-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUADTHERA 98466527 not registered Live/Pending |
ECO DM LAB Co., Ltd. 2024-03-25 |