FDA device listing
Breo Eye Massager: iSee 4, iSee M, EM005, See 7, See 7C, See X3, Care MG 3, Care MG 5; See 7R; Comfy 5; See 5K,Breo…
FDA device listing 1729453681 · Shenzhen Breo Technology Co., Ltd
Key facts
| Proprietary names | Breo Eye Massager: iSee 4, iSee M, EM005, See 7, See 7C, See X3, Care MG 3, Care MG 5; See 7R; Comfy 5; See 5K,Breo Massage Gun: Sport-M0220, Sport-M310, Sport-M0500,Breo Neck Massager: Neck N5 mini, N6 mini, N7, Neck N1 Pro, N5 mini S3, Z6, N7Elite,Breo Scalp3 Scalp Massaging Brush: Scalp 3,Breo Scalp Trilogy Massager: Scalp 3, Scalp 3S,Foot Massager: FM D191, Relax 5, Relax 3, Foot 3, Foot 3… |
|---|---|
| Owner/operator | Shenzhen Breo Technology Co., Ltd |
| Owner/operator number | 9093040 |
| 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 | Shenzhen Breo Technology Co., Ltd |
| Establishment registrations | 3006206425 |
| FEI numbers | 3006206425 |
| 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