Home / 510(k) Clearances / K230167

510(k) K230167

BACK 4 by Swims America Corp — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
January 20, 2023
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 Swims America Corp

  • K230037 — BACK 3 (July 19, 2023)
  • K220014 — RSHOCK (March 1, 2023)
  • K214090 — Back 3 COLOR (November 1, 2022)

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)
  • 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)