Data / Medical devices / United States / Shenb America, Inc.

Shenb America, Inc.: FDA-registered device maker in Brea, CA, United States, 8 510(k) clearances

Name: Shenb America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenb America, Inc. is registered with the FDA (registration 3045535064) in Brea, CA, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3045535064
Address: 655 N Berry St Ste A, Brea, CA, United States, 92821
Owner or operator: Shenb America, Inc. (10095947)
Roles: Complaint file establishment
First device listed: August 21, 2026
Registered through: 2026
Brand names listed: PlaDuo PRO System; PlaDuo System, Sunny, Sunny Plus (Sunny), Virtue RF, Vivace Pro; Vybe RF II, Vivace; Vybe RF

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Complaint file establishment	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K253926	Diacore	NGX	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
September 18, 2025	K251649	Sunny Plus (Sunny)	NFO	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
March 19, 2025	K242241	Sunny	GEI	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
September 25, 2024	K241535	Vybe RF II	GEI	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
September 26, 2023	K232233	Invisalign System with Mandibular Advancement Featuring Occlusal Blocks	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
July 6, 2023	K230968	VYBE RF Electrosurgical System	GEI	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
November 23, 2021	K211562	Virtue RF	GEI	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov
April 26, 2021	K193070	VIVACE Electrosurgical Device	GEI	Substantially Equivalent	ShenB Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.