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510(k) K241433

EVE Synergy (EVE-20M) by Weero Co., Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
May 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Weero Co., Ltd.

  • K253261 — Apollo Quattro (APQ-10M) (March 13, 2026)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240991 — eMVFit (MVF-10M) (October 9, 2024)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)
  • K232937 — BTL-899M (December 26, 2023)