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510(k) K240234

BTL-899MS by BTL Industries, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2024
Date Received
January 29, 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 BTL Industries, Inc.

  • K252561 — BTL-754FF (February 18, 2026)
  • K250309 — BTL-199 (August 7, 2025)
  • K243290 — BTL-785MJ (May 9, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241270 — BTL-754 (January 30, 2025)
  • K242532 — BTL-785BNF-E (December 13, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K232937 — BTL-899M (December 26, 2023)

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)
  • K240992 — eMVFit (MVF-10M) (October 10, 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)