Mechanical Table

FDA 510(k) K810445 · Fred Sammons, Inc.

Substantially Equivalent

510(k) numberK810445

Submission

Device name
Mechanical Table
Applicant
Fred Sammons, Inc.
Mchenry, IL, US
Received
February 19, 1981
Decision date
March 4, 1981
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

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K944308James Leckey Free StanderINW · Traditional James Leckey Design12/22/1994SE
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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

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K831549Arm SlingsILI · Traditional 06/30/1983SE
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K831550Finger Boniometer BK7506KQW · Traditional 06/24/1983SE
K831544Deluxe Traction Exercise Glove BK5035IOD · Traditional 06/24/1983SE
K831543Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional 06/24/1983SE
K831542Adjustable Polycentric Elbow HingeIQI · Traditional 06/24/1983SE
K831553Leg Drainage Bag Strap BK6011KNX · Traditional 06/16/1983SE
K831552Sorbothane Visco Inner Sole PadKNP · Traditional 06/08/1983SE

Questions and answers

When was Mechanical Table cleared by the FDA?

Mechanical Table (K810445) received a 510(k) decision of Substantially Equivalent on March 4, 1981, 13 days after the submission was received.

What is the product code of K810445?

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