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510(k) K930691

ACCUTRAC TRACTION UNIT by I-Rep, Inc. — Product Code ITH

K930691 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "ACCUTRAC TRACTION UNIT". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. I-Rep, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
February 10, 1993
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 I-Rep, Inc.

  • K930692 — LATHAM TABLE (February 2, 1994)
  • K861864 — MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT (July 14, 1986)
  • K854947 — REHABILITATION TABLES (January 3, 1986)
  • K851690 — ADJUSTABLE TREATMENT TABLES (May 7, 1985)
  • K842268 — VACUPULSE VACUUM UNIT (July 20, 1984)
  • K832940 — ROTAGYM (November 7, 1983)
  • K822906 — PHYSICAL MEDICINE & REHABILITATION EQUIP (October 15, 1982)

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