Jedmed J-Ii Chair

FDA 510(k) K896275 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK896275

Submission

Device name
Jedmed J-Ii Chair
Applicant
Jedmed Instrument Co.
St. Louis, MO, US
Received
October 30, 1989
Decision date
December 18, 1989
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
K791016Ulticare 2500 Treatment ChairFRK · Traditional American Health Care Industries, Inc.06/27/1979SE
K790955Cover GardFRK · Traditional Fem-Gard, Inc.06/20/1979SE
K790954Heel GardFRK · Traditional Fem-Gard, Inc.06/20/1979SE

More from Fem-Gard, Inc.

510(k)DeviceDecision
K150248ORL Video NasoPharyngo-LarngoscopeEQN · Traditional 07/23/2015SE
K132039Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional 02/21/2014SE
K021750Lid Chain Eyelid WeightsMML · Traditional 01/27/2003SE
K954184Jed-Light Fiberoptic Light SourceEQH · Traditional 11/13/1995SE
K944032Video Scope System (Laryngoscope)ENZ · Traditional 09/15/1995SE
K953457Jedmed Spectrum ENT CabinetETF · Traditional 08/11/1995SE
K950925Jedmed Laryngeal ScopeEOQ · Traditional 08/11/1995SE
K950785Hortmann Airmatic Air Caloric StimulatorKHH · Traditional 06/28/1995SE
K950078Microflow Irrigation SystemKMA · Traditional 06/21/1995SE
K944671Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional 02/07/1995SE

Questions and answers

When was Jedmed J-Ii Chair cleared by the FDA?

Jedmed J-Ii Chair (K896275) received a 510(k) decision of Substantially Equivalent on December 18, 1989, 49 days after the submission was received.

What is the product code of K896275?

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