FDA device listing
VIBRACOOL® FLEX:VC-2,VIBRACOOL® FOR PLANTAR FASCIITIS, GOUT:VC-Plantar,VIBRACOOL® KNEE/HEADACHE "EXTENDED…
FDA device listing 1841274501 · IBE Electronics Co., Ltd
Key facts
| Proprietary names | VIBRACOOL® FLEX:VC-2,VIBRACOOL® FOR PLANTAR FASCIITIS, GOUT:VC-Plantar,VIBRACOOL® KNEE/HEADACHE "EXTENDED FIT":VC-K,VIBRACOOL® PRO DME:VCP-DME,VIBRACOOL® PRO HEALTHCARE:VCP-200H,VIBRACOOL® PRO LOWER EXTREMITY:VCP-LE,VIBRACOOL® PRO UPPER EXTREMITY:VCP-UE,VIBRACOOL® WRIST/ELBOW "EASY FIT":VC-E |
|---|---|
| Owner/operator | IBE Electronics Co., Ltd |
| Owner/operator number | 10095068 |
| Product codes | IME |
| Device names | IME - Pack, Hot Or Cold, Reusable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5700 |
| Review panels | Physical Medicine |
| Registered establishments | IBE ELECTRONICS CO., LTD |
| Establishment registrations | 3043709758 |
| FEI numbers | 3043709758 |
| 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