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FDA 510(k)

SPECTRA Wearable 2

K-Number: K250208 · 2026-04-06

ApplicantUzinmedicare Co., Ltd.
Decision Date2026-04-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECTRA Wearable 2 is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K250208. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA Wearable 2?

SPECTRA Wearable 2 is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Uzinmedicare Co., Ltd.. The 510(k) number is K250208.

When did SPECTRA Wearable 2 receive FDA 510(k) clearance?

SPECTRA Wearable 2 received FDA 510(k) clearance on 2026-04-06, under 510(k) number K250208.

Who is the listed applicant for SPECTRA Wearable 2?

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

What is the FDA product code for SPECTRA Wearable 2?

The FDA product code for SPECTRA Wearable 2 is HGX.

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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.

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