FDA device listing
HUMAN TOUCH,IJOY,OS-8210 uDeluxe Max,OSIM Foot Massager,OSIM Hand held Massager,OSIM Massage Chair,OSIM OS-2212 uRoller…
FDA device listing 1806505778 · DT-OSIM HEALTHCARE APPLIANCES (SUZHOU) CO., LTD
Key facts
| Proprietary names | HUMAN TOUCH,IJOY,OS-8210 uDeluxe Max,OSIM Foot Massager,OSIM Hand held Massager,OSIM Massage Chair,OSIM OS-2212 uRoller X-Sports,OSIM OS-338 uPhoria Warm,OSIM OS-393S uSqueez 2 Smart,OSIM OS-393 uSqueez 2,OSIM OS-8208 uDream,OSIM OS-8211 uDiva 3,OSIM OS-8218 uLove 3,OSIM OS-860W uDeluxe,OSIM OS-888 uLove 2,OSIM OS-890 uDivine V,PRIVATE MASSEUSE |
|---|---|
| Owner/operator | DT-OSIM HEALTHCARE APPLIANCES (SUZHOU) CO., LTD |
| Owner/operator number | 9078625 |
| Product codes | ISA |
| Device names | ISA - Massager, Therapeutic, Electric |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5660 |
| Review panels | Physical Medicine |
| Registered establishments | DT-OSIM HEALTHCARE APPLIANCES (SUZHOU) CO., LTD |
| Establishment registrations | 3005405999 |
| FEI numbers | 3005405999 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database