FDA device listing
TheraPearl Ankle/Wrist Wrap with Strap (blue, color changing),TheraPearl Back Wrap with Strap (blue, color…
FDA device listing 1370903030 · Reckitt Benckiser LLC
Key facts
| Proprietary names | TheraPearl Ankle/Wrist Wrap with Strap (blue, color changing),TheraPearl Back Wrap with Strap (blue, color changing),TheraPearl Build Your Own Pack,TheraPearl Dragon,TheraPearl Eye Mask (blue, color changing, pink),TheraPearl Face Mask (blue, color changing),TheraPearl Fox,TheraPearl Frog,TheraPearl Husky,TheraPearl Knee Wrap with Strap (blue, color changing),TheraPearl Koala,TheraPearl Neck Wrap… |
|---|---|
| Owner/operator | Reckitt Benckiser LLC |
| Owner/operator number | 9004884 |
| 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 | Reckitt Benckiser LLC |
| Establishment registrations | 3011015568 |
| FEI numbers | 3011015568 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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