US-101L, US-103S— 510(k) K112520

Substantially Equivalent

Ito Co., Ltd.

FDA 510(k) clearance K112520 for US-101L, US-103S, Substantially Equivalent on 2011-10-26. Applicant: Ito Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ito Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2011-08-31
Decision date: 2011-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMI

K240788 — Ultrasound Stimulator2025-06-04
K230472 — Sonopuls 1902023-10-24
K222098 — ManaSport+2023-03-08
K210284 — ManaSport2022-04-26
K202788 — Sonomed IV, Sonomed V2021-12-23

More clearances from Ito Co., Ltd.

K203525 — D function2021-05-05
K081943 — MODEL ES-1302008-11-24
K081247 — TM-4002008-08-25
K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT2003-10-09
K022846 — SW-180 SHORTWAVE THERAPY UNIT2003-01-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.