Chair, Adjustable, Mechanical
FDA product code INN · Class I (low risk) · 21 CFR 890.3100 · Physical Medicine
26510(k) clearances
0PMA approvals
23recalls
Manufacturers
- Kaye Products, Inc. 3
- The Able Generation, Inc. 3
- Fred Sammons, Inc. 2
- Theradapt Products, Inc. 2
- Mednet, Inc. 2
- Thames Valley Children'S Centre 1
- Rifton Equipment For the Handicapped 1
- Broda Ent., Inc. 1
- Tri-S-Sales and Mfg. 1
- Innovative Medical Engineering, Inc. 1
- Mill-Tech Ent., Inc. 1
- Canadian Posture and Seating Centre, Inc. 1
- Pride Health Care, Inc. 1
- Camtec 1
- Global Medical Prods, Inc. 1
- Maddak, Inc. 1
- Reclining Wheels 1
- Progressive Productions , Ltd. 1
- Medical Device Consultants, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945650 | SpiffyINN · Traditional | Thames Valley Children'S Centre | 12/19/1994SE |
| K942397 | Theradapt Highchair/Stroller InsertINN · Traditional | Theradapt Products, Inc. | 06/22/1994SE |
| K930520 | Theradapt(R) Adjustable Classroom ChairINN · Traditional | Theradapt Products, Inc. | 03/24/1993SE |
| K923753 | Able Generation Therapy Tilt BenchINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923752 | Able Generation Play ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923750 | Able Generation Booster ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923095 | Kaye Model Kiao Pelvic/Thigh StabilizerINN · Traditional | Kaye Products, Inc. | 07/21/1992SE |
| K922061 | Chair, Adjustable, MechanicalINN · Traditional | Kaye Products, Inc. | 05/26/1992SE |
| K921272 | Activity ChairINN · Traditional | Rifton Equipment For the Handicapped | 04/07/1992SE |
| K904069 | Broda Nursing Care ChairINN · Traditional | Broda Ent., Inc. | 09/17/1990SE |
| K902951 | Shower-A-WayINN · Traditional | Tri-S-Sales and Mfg. | 07/25/1990SE |
| K902600 | The Companion Non-Electric Lift ChairINN · Traditional | Innovative Medical Engineering, Inc. | 06/21/1990SE |
| K896814 | Toi-LiftINN · Traditional | Mill-Tech Ent., Inc. | 02/20/1990SE |
| K894767 | Corner SeatINN · Traditional | Canadian Posture and Seating Centre, Inc. | 01/17/1990SE |
| K882090 | Hip SaverINN · Traditional | Pride Health Care, Inc. | 05/26/1988SE |
| K874060 | Converta-LitterINN · Traditional | Camtec | 12/10/1987SE |
| K862957 | Merivaara Geriatric Chair Model 455INN · Traditional | Global Medical Prods, Inc. | 08/21/1986SE |
| K862885 | Car SeatINN · Traditional | Mednet, Inc. | 08/14/1986SE |
| K862883 | Orthopedic SeatsINN · Traditional | Mednet, Inc. | 08/14/1986SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | Maddak, Inc. | 05/09/1984SE |
| K832511 | Reclining WheelsINN · Traditional | Reclining Wheels | 08/31/1983SE |
| K823277 | The Progressive ChairINN · Traditional | Progressive Productions , Ltd. | 12/13/1982SE |
| K821651 | E-Z Up Artherapedic ChairINN · Traditional | Medical Device Consultants, Inc. | 06/24/1982SE |
| K812399 | Chair, Adjustable, MechanicalINN · Traditional | Kaye Products, Inc. | 09/14/1981SE |
| K812347 | Raised Chair W/Foot PlatformINN · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K811484 | Seating StoolsINN · Traditional | Fred Sammons, Inc. | 06/16/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1498-2026 Class II | Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code:…Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat… | Raz Design Inc | 01/05/2026Open, Classified |
| Z-0880-2023 Class II | ActiveAid 922, Shower/Commode ChairDevice manufactured with a component with affects the foldability of the frame, not allowing it to be… | Altimate Medical, Inc. | 11/30/2022Terminated |
| Z-0569-2022 Class II | R82 by ETAC Push Brace for High-LowThe chrome surface of the push brace can crack during use, potentially cutting the user. | R82 A/S | 12/08/2021Terminated |
| Z-2209-2021 Class II | Prime TC-transport chair intended for medical purposes to assist a person in performing…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-2403-2015 Class II | Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2402-2015 Class II | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2401-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2400-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2399-2015 Class II | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2398-2015 Class II | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2397-2015 Class II | Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2396-2015 Class II | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2395-2015 Class II | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2394-2015 Class II | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2393-2015 Class II | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2392-2015 Class II | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2391-2015 Class II | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | Winco Mfg., LLC | 04/02/2015Terminated |
| Z-2023-2014 Class II | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean…The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the… | Invacare Corporation | 06/25/2014Terminated |
| Z-0167-2014 Class II | Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet…The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and… | Invacare Corporation | 08/31/2013Terminated |
| Z-1807-2013 Class II | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower…Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil… | Etac Supply Center Ab | 05/23/2013Terminated |
| Z-0270-2012 | "***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model…On June 26, 2011 Uplift Technologies Inc. Nova Scotia, Canada initiated a recall of the Uplift Commode… | Uplift Technologies Inc. | 06/27/2011Terminated |
| Z-2040-2009 | Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee…The plastic buckles on the hip belts of the 4-Point Pelvic Harness may break. | Patterson Medical Holdings, Inc. | 04/17/2009Terminated |
| Z-0318-2009 | Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic…Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were… | Community Products, LLC | 09/12/2008Terminated |