745-M (Magnum)

FDA 510(k) K922980 · Tri W-G, Inc.

Substantially Equivalent

510(k) numberK922980

Submission

Device name
745-M (Magnum)
Applicant
Tri W-G, Inc.
Valley City, ND, US
Received
June 22, 1992
Decision date
July 13, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JFB – Table, Physical Therapy, Multi Function
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5880
Specialty
Physical Medicine

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More from Ceragem International, Inc.

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K941720Model 747 and 747-30 Exam/Treatment TableINQ · Traditional 05/06/1994SE
K936303Treatment Table ModificationINQ · Traditional 03/18/1994SE
K933119Hi-Lo Treatment TablesINQ · Traditional 10/12/1993SE
K932746Model T4501,T4502,T4503,T4504,T4504 Tilt TableINQ · Traditional 07/21/1993SE
K930802Models 642 & 643 Tilt Exam/Treatment TableINQ · Traditional 03/22/1993SE
K925594MDL 29001 Medi Elec-Mech Tilt Exam/Treatment TableINQ · Traditional 02/12/1993SE
K923325Model 600 Medical Treatment TableINQ · Traditional 07/21/1992SE
K920585Mat Table, 8100 Series Mat PlatformINQ · Traditional 04/07/1992SE

Questions and answers

When was 745-M (Magnum) cleared by the FDA?

745-M (Magnum) (K922980) received a 510(k) decision of Substantially Equivalent on July 13, 1992, 21 days after the submission was received.

What is the product code of K922980?

The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.