Aid, Transfer
FDA product code IKX · Class I (low risk) · 21 CFR 890.5050 · Physical Medicine
18510(k) clearances
0PMA approvals
20recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862895 | TricyclesIKX · Traditional | Mednet, Inc. | 08/13/1986SE |
| K842650 | Wall Grab Bars 98130-98136IKX · Traditional | Guardian Products Co., Inc. | 08/10/1984SE |
| K831541 | Tub Transfer Bench BK6481IKX · Traditional | Fred Sammons, Inc. | 06/02/1983SE |
| K823640 | Bath Tub Safety BarIKX · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823639 | Board to Transfer Paralyzed Patient FromIKX · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823634 | Chair or Bed Leg ExtendersIKX · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823154 | Shower Stool W/HandlesIKX · Traditional | Orthion Corp. | 11/05/1982SE |
| K823153 | Bath Tub Seat & Bath BoardIKX · Traditional | Orthion Corp. | 11/05/1982SE |
| K821903 | Disc-O-AidIKX · Traditional | M. Dahm International Aps | 07/20/1982SE |
| K821010 | Bathtub Transfer BenchIKX · Traditional | Guardian Products Co., Inc. | 04/21/1982SE |
| K813629 | BK-6111 Hi-D Transfer BoardIKX · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812475 | Transfer BenchIKX · Traditional | Maddak, Inc. | 09/14/1981SE |
| K810449 | Transfer AidsIKX · Traditional | Fred Sammons, Inc. | 03/04/1981SE |
| K810275 | Grab BarsIKX · Traditional | Maddak, Inc. | 02/12/1981SE |
| K792247 | Taylor Patient Transfer BoardIKX · Traditional | Taylor Medical Equipment | 11/30/1979SE |
| K781201 | Board, Transfer, FenderIKX · Traditional | Fred Sammons, Inc. | 07/31/1978SE |
| K780935 | Grab BarIKX · Traditional | Orthopedic Equipment Co., Inc. | 06/19/1978SE |
| K772417 | Sliding BoardIKX · Traditional | Fred Sammons, Inc. | 01/05/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0838-2025 Class II | NOA Medical Industries Behavioral Health Hospital bed side rails, Product number…Red button used to engage side rails can break or become stuck making it difficult to engage the side rail. | NOA Medical Industries Inc | 11/05/2024Open, Classified |
| Z-0055-2021 Class II | Quick Release Gait Belt, 60The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation. | Medline Industries Inc | 09/15/2020Open, Classified |
| Z-0164-2018 Class II | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially… | Medline Industries Inc | 08/10/2017Terminated |
| Z-0163-2018 Class II | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially… | Medline Industries Inc | 08/10/2017Terminated |
| Z-2626-2017 Class II | ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH…ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow… | EOS Imaging | 05/30/2017Terminated |
| Z-1613-2015 Class II | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch.…Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. | Handicare USA, Inc. | 03/26/2015Terminated |
| Z-0303-2017 Class II | ReTurn 7500/7500 Aid, transferDuring the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle… | Handicare USA, Inc. | 04/15/2014Terminated |
| Z-1429-2012 | Norco Folding Shower Bench; Features a nonskid surface and handholds for added security.…Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough… | North Coast Medical Inc | 03/20/2012Terminated |
| Z-0465-2010 | Shower Seat, Rotating, Catalog number 727152100Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0464-2010 | Shower Seat, Non-rotating, Catalog number 727152000Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0463-2010 | Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960RSafety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0462-2010 | Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120…Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0461-2010 | Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0460-2010 | Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and…Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0459-2010 | Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001Safety chair used in shower/bath may not meet specifications for weight load. | Nutech Manufacturing Corp | 07/09/2009Terminated |
| Z-0599-2009 | Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" Model: 72109Misassembled gait (transfer aid) belt. | AliMed Corporation | 10/30/2008Terminated |
| Z-0598-2009 | Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108Misassembled gait (transfer aid) belt. | AliMed Corporation | 10/30/2008Terminated |
| Z-2298-2008 | Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Zimmer Inc., Warsaw, IN…If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the… | Zimmer Inc. | 07/07/2008Terminated |
| Z-2297-2008 | Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc.…If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the… | Zimmer Inc. | 07/07/2008Terminated |
| Z-2296-2008 | Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable…If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the… | Zimmer Inc. | 07/07/2008Terminated |