Apollo Quattro (APQ-10M)— 510(k) K253542
Substantially EquivalentWeero 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.
Summary
Weero's Apollo Quattro (APQ-10M) is filed under IPF, powered muscle stimulators. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 890.5850. The Neurology review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
Weero filed from Suwon, South Korea. The decision came 206 calendar days after FDA received it (November 14, 2025 to June 8, 2026).
Clearance details
- Applicant
- Weero Co., Ltd.
- Product code
- Product code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon, KR
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