Home / 510(k) Clearances / K843581

510(k) K843581

PROM NAID by Lossing Orthopedic, Inc. — Product Code ITH

K843581 is an FDA 510(k) premarket notification submitted by Lossing Orthopedic, Inc. for the device "PROM NAID". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Lossing Orthopedic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
September 11, 1984
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 Lossing Orthopedic, Inc.

  • K900475 — DISTRAC(TM) TABLE (May 24, 1990)
  • K864152 — BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE (February 5, 1987)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K840551 — MOBILIZER (March 23, 1984)
  • K823236 — BACK ON TRACK INVERSION THERAPY & EXER (January 21, 1983)
  • K813017 — NECKTRAC (November 25, 1981)
  • K802555 — COTTRELL 90/90 BACKTRAC (October 31, 1980)

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