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 a medical device manufactured by Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under approval 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. It is manufactured by Uzinmedicare Co., Ltd.. The 510(k) number is K250208.
When was SPECTRA Wearable 2 approved by the FDA?
SPECTRA Wearable 2 received FDA 510(k) clearance on 2026-04-06, under approval number K250208.
What company makes SPECTRA Wearable 2?
SPECTRA Wearable 2 is manufactured by Uzinmedicare Co., Ltd..
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.