Acratrac R

FDA 510(k) K811438 · Avratronics Corp.

Substantially Equivalent

510(k) numberK811438

Submission

Device name
Acratrac R
Applicant
Avratronics Corp.
Mchenry, IL, US
Received
May 22, 1981
Decision date
June 9, 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

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
K810057Galvanator 725IPF · Traditional 01/23/1981SE

Questions and answers

When was Acratrac R cleared by the FDA?

Acratrac R (K811438) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 18 days after the submission was received.

What is the product code of K811438?

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