AMX-110, Amx-Ii and Amx-Iii

FDA 510(k) K884340 · Dyna-Med

Substantially Equivalent

510(k) numberK884340

Submission

Device name
AMX-110, Amx-Ii and Amx-Iii
Applicant
Dyna-Med
Victoria, TX, US
Received
October 14, 1988
Decision date
January 24, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ILZ – Accessories, Traction
Device class
Class I (low risk)
Regulation
21 CFR 890.5925
Specialty
Physical Medicine

Other 510(k)s with product code ILZ

510(k)DeviceApplicantDecision
K921711Flexion Distration SupportILZ · Traditional Altoona Medical Supply07/13/1992SE
K895382Vibra-Trac Traction TableILZ · Traditional Vibra-Trac Industries10/16/1989SE
K852398Vector Bar Suspension/Traction UnitILZ · Traditional Powlan Manufacturing Co.08/12/1985SE
K844490Traction AccessoriesILZ · Traditional Jerome Medical02/21/1985SE
K831135Saunders #7080 Cervical Traction SysILZ · Traditional Chattanooga Group, Inc.06/24/1983SE
K830245Head HalterILZ · Traditional Warm & Form, Orthopedic Materials03/09/1983SE
K823659Pelvic Traction BeltILZ · Traditional Warm & Form, Orthopedic Materials12/30/1982SE
K823166Pelvic Traction BeltILZ · Traditional Warm & Form, Orthopedic Materials11/10/1982SE
K820663Boger Auto-Traction DeviceILZ · Traditional D.C. Medical Device, Inc.05/03/1982SE
K791808Cervi-TracILZ · Traditional Dr. K.G. Rude10/01/1979SE

More from Dr. K.G. Rude

510(k)DeviceDecision
K884578Polarix 2 and Polarix 2EJAA · Traditional 02/09/1989SE
K863504Obstetrical Kit · Traditional 10/22/1986SESD
K760258Bite Stick, DynaJXL · Traditional 07/26/1976SE

Questions and answers

When was AMX-110, Amx-Ii and Amx-Iii cleared by the FDA?

AMX-110, Amx-Ii and Amx-Iii (K884340) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 102 days after the submission was received.

What is the product code of K884340?

The FDA product code is ILZ – Accessories, Traction, a Class I (low risk) device regulated under 21 CFR 890.5925.