Apollo Quattro (APQ-10M)— 510(k) K253542

Substantially Equivalent

Weero Co., Ltd.

FDA 510(k) clearance K253542 for Apollo Quattro (APQ-10M), Substantially Equivalent on 2026-06-08. Applicant: Weero Co., Ltd.. Device class: 2.

Clearance details

Applicant: Weero Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2025-11-14
Decision date: 2026-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Weero Co., Ltd.

K253261 — Apollo Quattro (APQ-10M)2026-03-13
K240992 — eMVFit (MVF-10M)2024-10-10
K240991 — eMVFit (MVF-10M)2024-10-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.