R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213

FDA 510(k) K861350 · Tri W-G, Inc.

Substantially Equivalent

510(k) numberK861350

Submission

Device name
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
Applicant
Tri W-G, Inc.
Valley City, ND, US
Received
April 7, 1986
Decision date
May 2, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
INW – Table, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3750
Specialty
Physical Medicine

Other 510(k)s with product code INW

510(k)DeviceApplicantDecision
K944308James Leckey Free StanderINW · Traditional James Leckey Design12/22/1994SE
K944307James Leckey Prone StanderINW · Traditional James Leckey Design12/22/1994SE
K943975Euro Tech Platinum Chiropractic TableINW · Traditional Progressive Electrical Therapeutics09/29/1994SE
K943974Euro Tech Marquise Chiropractic TableINW · Traditional Progressive Electrical Therapeutics09/29/1994SE
K940238Tumble Forms Junior TristanderINW · Traditional Camp Intl., Inc.03/07/1994SE
K932238Eco. Hi-Low Treatment Tables Various Model NumbersINW · Traditional Bailey Mfg. Co.07/22/1993SE
K932234Professional & Econmy Tilt Table 9500 9520INW · Traditional Bailey Mfg. Co.07/22/1993SE
K932233Economy Hi-Low Work Table (Manual) Model 3405INW · Traditional Bailey Mfg. Co.07/22/1993SE
K932231Economy Hi-Low Mat Table #4110 Thru 4117INW · Traditional Bailey Mfg. Co.07/22/1993SE
K931635Treatment Tables, Manually ActivatedINW · Traditional Med Mart, Inc.07/21/1993SE

More from Med Mart, Inc.

510(k)DeviceDecision
K960196Tri W-G, Inc Table, Tilt/Exam/Treatment Model 777INQ · Traditional 02/07/1996SE
K945163EchocardiographyLGX · Traditional 02/17/1995SE
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
K922980745-M (Magnum)JFB · Traditional 07/13/1992SE

Questions and answers

When was R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213 cleared by the FDA?

R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213 (K861350) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 25 days after the submission was received.

What is the product code of K861350?

The FDA product code is INW – Table, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3750.