Flex D-4000

FDA 510(k) K951419 · U.S. Table, Inc.

Substantially Equivalent

510(k) numberK951419

Submission

Device name
Flex D-4000
Applicant
U.S. Table, Inc.
Glen Allen, VA, US
Received
March 28, 1995
Decision date
June 30, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
K952600EVT-5000BXINQ · Traditional U.S. Table, Inc.06/22/1995SE
K952359The Hill Adjustable HA90CINQ · Traditional Hill Laboratories Co.06/22/1995SE
K952358The Hill Adjustable P.T. Mobilization TableINQ · Traditional Hill Laboratories Co.06/22/1995SE

More from Hill Laboratories Co.

510(k)DeviceDecision
K953621EVT-3300INQ · Traditional 11/14/1995SE
K953622PTT 6200 Elevation Therapy TableINQ · Traditional 09/11/1995SE
K952600EVT-5000BXINQ · Traditional 06/22/1995SE
K951228ASH-7000ITH · Traditional 05/17/1995SE

Questions and answers

When was Flex D-4000 cleared by the FDA?

Flex D-4000 (K951419) received a 510(k) decision of Substantially Equivalent on June 30, 1995, 94 days after the submission was received.

What is the product code of K951419?

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