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510(k) K081247

TM-400 by Ito Co., Ltd. — Product Code ITH

K081247 is an FDA 510(k) premarket notification submitted by Ito Co., Ltd. for the device "TM-400". The FDA issued a decision of Substantially Equivalent on August 25, 2008. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Ito Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2008
Date Received
May 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

Other clearances by Ito Co., Ltd.

  • K203525 — D function (May 5, 2021)
  • K112520 — US-101L, US-103S (October 26, 2011)
  • K081943 — MODEL ES-130 (November 24, 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 ITH

  • K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) (July 18, 2025)
  • K243366 — DRX9000C-SL Cervical Spinal Decompression System (June 18, 2025)
  • K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (February 22, 2024)
  • K222912 — c1Trac (May 16, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)
  • K150695 — Modpod (August 13, 2015)
  • K131983 — ITRAC CERVICAL TRACTION SYSTEM (September 10, 2014)
  • K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0 (February 6, 2014)
  • K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (February 1, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)

FDA data resources