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510(k) K210284

ManaSport by Manamed, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2022
Date Received
February 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Manamed, Inc.

  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC) (November 3, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K211253 — PlasmaWave (May 26, 2021)
  • K200353 — ManaFlow (August 6, 2020)
  • K200351 — PlasmaFlight (August 5, 2020)
  • K160318 — PlasmaFlow (April 1, 2016)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K160075 — Accent XL (August 17, 2016)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)