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FDA 510(k)

Sunny Plus (Sunny)

K-Number: K251649 · 2025-09-18

Decision Date2025-09-18
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sunny Plus (Sunny) is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K251649. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunny Plus (Sunny)?

Sunny Plus (Sunny) is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K251649.

When did Sunny Plus (Sunny) receive FDA 510(k) clearance?

Sunny Plus (Sunny) received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251649.

Who is the listed applicant for Sunny Plus (Sunny)?

The FDA 510(k) record lists ShenB Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunny Plus (Sunny)?

The FDA product code for Sunny Plus (Sunny) is NFO.

Other records listing ShenB Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 11 devices →

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.