FDA device listing
Buzzy® Healthcare,Buzzy® LadyBuzz,Buzzy® Mini Healthcare,Buzzy® Mini Personal,Buzzy® Pro,Buzzy® XL Personal,VibraCool®…
FDA device listing 1267384742 · MMJ Labs dba Pain Care Labs
Key facts
| Proprietary names | Buzzy® Healthcare,Buzzy® LadyBuzz,Buzzy® Mini Healthcare,Buzzy® Mini Personal,Buzzy® Pro,Buzzy® XL Personal,VibraCool® Easy Fit,VibraCool® Extended,VibraCool® Flex,VibraCool® Plantar,VibraCool® Pro Durable Medical Equipment (DME),VibraCool® Pro Healthcare,VibraCool® Pro Lower Extremity (LE),VibraCool® Pro Upper Extremity (UE) |
|---|---|
| Owner/operator | MMJ Labs dba Pain Care Labs |
| Owner/operator number | 10027555 |
| Premarket submissions | K202993 |
| Product codes | IME, PHW |
| Device names | IME - Pack, Hot Or Cold, Reusable, PHW - Cold Pack And Vibrating Massager |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5700, 890.5975 |
| Review panels | Physical Medicine |
| Registered establishments | Pain Care Labs |
| Establishment registrations | 3007439125 |
| FEI numbers | 3007439125 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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