Adaptor, Hygiene
FDA product code ILS · Class I (low risk) · 21 CFR 890.5050 · Physical Medicine
31510(k) clearances
0PMA approvals
4recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852049 | Medical Toilet SeatILS · Traditional | Pedro Aleman | 06/24/1985SE |
| K842651 | Commode Chair 98200ILS · Traditional | Guardian Products Co., Inc. | 08/07/1984SE |
| K831547 | Raised Toilet Seats & Nail ClippersILS · Traditional | Fred Sammons, Inc. | 06/08/1983SE |
| K830853 | Lavatory Seat HeightenerILS · Traditional | Lic-Orthion | 06/08/1983SE |
| K830425 | Toilet Seat RaisedILS · Traditional | Maddak, Inc. | 05/09/1983SE |
| K830852 | Shower Stool W/HandlesILS · Traditional | Lic-Orthion | 04/05/1983SE |
| K823641 | Bathing Chair for ChildILS · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823626 | Disposable Tooth BrushILS · Traditional | Fred Sammons, Inc. | 12/30/1982SE |
| K823606 | Plastic Break Resistant MirrorILS · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
| K823155 | Lavatory Seat HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
| K821860 | BK-6477 the Derby Raised Toilet SeatILS · Traditional | Fred Sammons, Inc. | 07/02/1982SE |
| K821638 | Hygiene AdaptorsILS · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K821009 | Bathtub Grab BarILS · Traditional | Guardian Products Co., Inc. | 04/21/1982SE |
| K813635 | Childs Toilet Trainer Hygiene AidsILS · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812483 | Secura Bath SeatILS · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812352 | Hygiene AdaptorsILS · Traditional | Fred Sammons, Inc. | 09/14/1981SE |
| K811301 | TubmateILS · Traditional | American Stair-Glide Corp. | 05/27/1981SE |
| K810456 | Hygiene AdaptorsILS · Traditional | Fred Sammons, Inc. | 03/04/1981SE |
| K802511 | Garelick CommodeILS · Traditional | Garelick Mfg. Co. | 11/12/1980SE |
| K791423 | Toilet Trainer for Handicapped ChildILS · Traditional | Kaye Products, Inc. | 08/10/1979SE |
| K790531 | Anus StimulatorILS · Traditional | Maddak, Inc. | 04/26/1979SE |
| K790175 | Semi-Reclining Bath Chari & BeltILS · Traditional | Fred Sammons, Inc. | 02/22/1979SE |
| K790178 | Water Powered Bath Chair LiftILS · Traditional | Fred Sammons, Inc. | 02/08/1979SE |
| K781614 | Motor Riser Tolit LiftILS · Traditional | Motor Riser Chairs , Ltd. | 10/03/1978SE |
| K781205 | Toilet AidILS · Traditional | Fred Sammons, Inc. | 07/31/1978SE |
| K761130 | Bathtub RailsILS · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761129 | Contoured Raised Toilet SeatILS · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761127 | Long Handled Bath BrushILS · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761126 | Extra Large Long Handled SpongeILS · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761125 | Long Handled SpongeILS · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1353-2021 Class II | Drop Arm Versamode"The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. | Gf Health Products | 03/24/2021Terminated |
| Z-1683-2020 Class II | Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The…The firm received reports of a number of broken latches on the floorsitter. | James Leckey Design Ltd | 02/18/2020Open, Classified |
| Z-2381-2015 Class II | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat…The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the… | Etac Supply Center Ab | 07/12/2015Terminated |
| Z-2073-2015 Class II | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have…The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has… | Etac Supply Center Ab | 06/15/2015Terminated |