| Primary Device ID | 06978949461548 |
| NIH Device Record Key | 34ddc96a-99f2-45c6-91f5-559d93d1154f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rollator |
| Version Model Number | W2301 |
| Company DUNS | 544392592 |
| Company Name | Zhejiang Innuovo Rehabilitation Devices 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06978949461548 [Primary] |
| ITJ | Walker, Mechanical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-21 |
| Device Publish Date | 2025-08-13 |
| 06978949462798 - Mobility Scooter | 2025-09-16 |
| 06978949462804 - Mobility Scooter | 2025-09-16 |
| 06978949461548 - Rollator | 2025-08-21 |
| 06978949461548 - Rollator | 2025-08-21 |
| 06978949460114 - Mobility Scooter | 2025-08-20 |
| 06978949460169 - Mobility Scooter | 2025-08-20 |
| 06978949460190 - Mobility Scooter | 2025-08-20 |
| 06978949460602 - Mobility Scooter | 2025-08-20 |
| 06978949460978 - Power Wheelchair | 2025-08-20 |