Manual and Motorized Flexion Distraction Tables

FDA 510(k) K904950 · Leander Research, Mfg & Distr., Inc.

Substantially Equivalent

510(k) numberK904950

Submission

Device name
Manual and Motorized Flexion Distraction Tables
Applicant
Leander Research, Mfg & Distr., Inc.
Port Orchard, WA, US
Received
November 2, 1990
Decision date
November 26, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
INQ – Table, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.3760
Specialty
Physical Medicine

Other 510(k)s with product code INQ

510(k)DeviceApplicantDecision
K960336Cardon Physical Therapy Table Model R27645INQ · Traditional Cardon Rehabilitation Products, Inc.02/13/1996SE
K960334Cardon Physical Therapy Table Model R27116INQ · Traditional Cardon Rehabilitation Products, Inc.02/13/1996SE
K960332Cardon Physical Therapy Table Model R28598INQ · Traditional Cardon Rehabilitation Products, Inc.02/13/1996SE
K960196Tri W-G, Inc Table, Tilt/Exam/Treatment Model 777INQ · Traditional Tri W-G, Inc.02/07/1996SE
K953621EVT-3300INQ · Traditional U.S. Table, Inc.11/14/1995SE
K953622PTT 6200 Elevation Therapy TableINQ · Traditional U.S. Table, Inc.09/11/1995SE
K952357The Hill Adjustable Podiatry ModelINQ · Traditional Hill Laboratories Co.07/06/1995SE
K951419Flex D-4000INQ · Traditional U.S. Table, Inc.06/30/1995SE
K952600EVT-5000BXINQ · Traditional U.S. Table, Inc.06/22/1995SE
K952359The Hill Adjustable HA90CINQ · Traditional Hill Laboratories Co.06/22/1995SE

Questions and answers

When was Manual and Motorized Flexion Distraction Tables cleared by the FDA?

Manual and Motorized Flexion Distraction Tables (K904950) received a 510(k) decision of Substantially Equivalent on November 26, 1990, 24 days after the submission was received.

What is the product code of K904950?

The FDA product code is INQ – Table, Powered, a Class I (low risk) device regulated under 21 CFR 890.3760.