Ulticare 2500 Treatment Chair

FDA 510(k) K791016 · American Health Care Industries, Inc.

Substantially Equivalent

510(k) numberK791016

Submission

Device name
Ulticare 2500 Treatment Chair
Applicant
American Health Care Industries, Inc.
Mchenry, IL, US
Received
June 1, 1979
Decision date
June 27, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FRK – Chair, Examination And Treatment
Device class
Class I (low risk)
Regulation
21 CFR 880.6140
Specialty
General Hospital

Other 510(k)s with product code FRK

510(k)DeviceApplicantDecision
K896275Jedmed J-Ii ChairFRK · Traditional Jedmed Instrument Co.12/18/1989SE
K790955Cover GardFRK · Traditional Fem-Gard, Inc.06/20/1979SE
K790954Heel GardFRK · Traditional Fem-Gard, Inc.06/20/1979SE

Questions and answers

When was Ulticare 2500 Treatment Chair cleared by the FDA?

Ulticare 2500 Treatment Chair (K791016) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 26 days after the submission was received.

What is the product code of K791016?

The FDA product code is FRK – Chair, Examination And Treatment, a Class I (low risk) device regulated under 21 CFR 880.6140.