FDA device listing
KUM-046 Portable Skin Renewal,KUM-048 Portable Supersonic Massager,KUM-103 Skin Firmer,KUM-2005 Skin Firmer,KUM-220…
FDA device listing 1424560217 · KING ULTRASONIC CO., LTD.
Key facts
| Proprietary names | KUM-046 Portable Skin Renewal,KUM-048 Portable Supersonic Massager,KUM-103 Skin Firmer,KUM-2005 Skin Firmer,KUM-220 Portable Massager,KUP-2000 Therapy Device,KUP-200 Portable Therapeutic Massager,KUP-3000 Therapy Device,KUP-300 Portable Therapeutic Massager,LM1402 DERMABLU,LM1403 DERMARED |
|---|---|
| Owner/operator | KING ULTRASONIC CO., LTD. |
| Owner/operator number | 9039108 |
| 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 | KING ULTRASONIC CO., LTD. |
| Establishment registrations | 9615076 |
| FEI numbers | 3002775750 |
| 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