Tumble Forms Tristander

FDA 510(k) K922965 · Tumble Forms

Substantially Equivalent

510(k) numberK922965

Submission

Device name
Tumble Forms Tristander
Applicant
Tumble Forms
Great Neck, NY, US
Received
June 19, 1992
Decision date
July 13, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

Questions and answers

When was Tumble Forms Tristander cleared by the FDA?

Tumble Forms Tristander (K922965) received a 510(k) decision of Substantially Equivalent on July 13, 1992, 24 days after the submission was received.

What is the product code of K922965?

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