Chair And Table, Medical

FDA product code KMN · Class I (low risk) · 21 CFR 880.6140 · General Hospital

3510(k) clearances
0PMA approvals
3recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K894788Dmi Series 90 Examination TableKMN · Traditional M.D. Intl., Inc.09/08/1989SE
K801936Pad, Examining TableKMN · Traditional Volunteer Blind Industries, Inc.08/27/1980SE
K761110Bed TrayKMN · Traditional Fred Sammons, Inc.12/02/1976SE

Recalls

RecallProductFirmInitiated
Z-2220-2021 Class IIStretcher Chair-for use in all acute care hospitals and medical outpatient services…Medical devices intended for use in a healthcare facility were distributed to residential customers and may… Stryker Medical Division of Stryker…05/12/2021Open, Classified
Z-2219-2021 Class IIMichael Graves with Stryker Highback Chair-intended for pediatric and adult person guest…Medical devices intended for use in a healthcare facility were distributed to residential customers and may… Stryker Medical Division of Stryker…05/12/2021Open, Classified
Z-2461-2012 Class IIInvacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria…On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781… Invacare Corporation08/06/2012Terminated