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510(k) K240992

eMVFit (MVF-10M) by Weero Co., Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2024
Date Received
April 11, 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)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K240991 — eMVFit (MVF-10M) (October 9, 2024)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 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)