Medi-Plinth

FDA 510(k) K924905 · Medi-Man Rehabilitation Products, Inc.

Substantially Equivalent

510(k) numberK924905

Submission

Device name
Medi-Plinth
Applicant
Medi-Man Rehabilitation Products, Inc.
Canada, L4w 1p4, CA
Received
September 29, 1992
Decision date
February 16, 1993
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
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

More from Hill Laboratories Co.

510(k)DeviceDecision
K992779A-2000 Bathing Systems; Hydrosonic Bathin SystemILJ · Traditional 01/13/2000SE
K925195Malibu Bathing SystemILJ · Traditional 10/17/1994SE
K844976Medi-Man Water Powered Bath Lift & Hydraulic LiftFSA · Traditional 04/01/1985SE

Questions and answers

When was Medi-Plinth cleared by the FDA?

Medi-Plinth (K924905) received a 510(k) decision of Substantially Equivalent on February 16, 1993, 140 days after the submission was received.

What is the product code of K924905?

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