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510(k) K112520

US-101L, US-103S by Ito Co., Ltd. — Product Code IMI

K112520 is an FDA 510(k) premarket notification submitted by Ito Co., Ltd. for the device "US-101L, US-103S". The FDA issued a decision of Substantially Equivalent on October 26, 2011. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Ito Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2011
Date Received
August 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Ito Co., Ltd.

  • K203525 — D function (May 5, 2021)
  • K081943 — MODEL ES-130 (November 24, 2008)
  • K081247 — TM-400 (August 25, 2008)
  • K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT (October 9, 2003)
  • K022846 — SW-180 SHORTWAVE THERAPY UNIT (January 28, 2003)
  • K990787 — TRIO 300 (October 20, 1999)
  • K992545 — TM-300 TRACTION SYSTEM (September 1, 1999)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • 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)

FDA data resources