# Shenb America, Inc. (other, Brea, CA): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Shenb America, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Brea, CA, US |
| New listings | 10 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Massager, Vacuum, Radio Frequency Induced Heat; Stimulator, Muscle, Powered, For Muscle Conditioning; Aligner, Sequential |
| Product codes | GEI, NFO, PBX, NGX, NXC |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Neurology, Physical Medicine, Dental |
| Brand names | Vivace; Vybe RF; Sunny Plus (Sunny); Virtue RF; Vivace Pro; Vybe RF II; Sunny; PlaDuo PRO System; PlaDuo System |
| First new listing | 2026-08-21 |
| Latest new listing | 2026-08-21 |
| FDA registration number | 3045535064 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.