Us-101l, Us-103S

510(k) Number

K112520 ↗

FDA product code

IMI

Device class

Class II

Regulation

21 CFR Part 890.5300

Advisory committee

Physical Medicine

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat).

• ACCUSONIC ADVANTAGE by Metron Medical Australia, Pty, Ltd.
• MODIFIED SONICATOR 720, MODEL ME720 by METTLER ELECTRONICS CORP.
• EXONIX by Fibra Sonics, Inc.
• TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 by Tru-Trac Therapy Products, Inc.
• SONICATOR 740, MODEL ME 740 by METTLER ELECTRONICS CORP.
• MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 by Metron Medical Australia, Pty, Ltd.
• RICH-MAR MODEL 25 ULTRASOUND by Rich-Mar Corp.
• MODEL 118 PULSE MEGASON by Birtcher Corp.
• SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT by Henley Intl.
• SONOPULSE/ SONOPULSE III by Ibramed- Industria Brazileria DE Equipamentos Medi

• D function

  Class II

  FDA 510(k) K203525 Active Cleared 5 May 2021 GUDID on market

• Es-130

  Unclassified

  CE/MDD FDA 510(k) K081943 Active Cleared 24 Nov 2008 +1authorizations

• Tm-400

  Class II

  FDA 510(k) K081247 Active Cleared 25 Aug 2008 GUDID on market

• Es-160

  Class II

  FDA 510(k) K051020 Active Cleared 24 Feb 2006 GUDID on market

See all devices from Ito Co., Ltd. →