Product code ILS
- Device name
- Adaptor, Hygiene
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5050
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | 1985-06-24 |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | 1984-08-07 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | 1983-06-08 |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | 1983-06-08 |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | 1983-05-09 |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | 1983-04-05 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | 1983-01-21 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | 1982-12-28 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | 1982-07-02 |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1982-06-11 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | 1982-04-21 |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | 1982-01-19 |
| K812483 | SECURA BATH SEAT | Maddak, Inc. | 1981-09-14 |
| K812352 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1981-09-14 |
| K811301 | TUBMATE | American Stair-Glide Corp. | 1981-05-27 |
| K810456 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1981-03-04 |
| K802511 | GARELICK COMMODE | Garelick Mfg. Co. | 1980-11-12 |
| K791423 | TOILET TRAINER FOR HANDICAPPED CHILD | Kaye Products, Inc. | 1979-08-10 |
| K790531 | ANUS STIMULATOR | Maddak, Inc. | 1979-04-26 |
| K790175 | SEMI-RECLINING BATH CHARI & BELT | Fred Sammons, Inc. | 1979-02-22 |
| K790178 | WATER POWERED BATH CHAIR LIFT | Fred Sammons, Inc. | 1979-02-08 |
| K781614 | MOTOR RISER TOLIT LIFT | Motor Riser Chairs , Ltd. | 1978-10-03 |
| K781205 | TOILET AID | Fred Sammons, Inc. | 1978-07-31 |
| K761125 | LONG HANDLED SPONGE | Fred Sammons, Inc. | 1976-12-02 |
| K761130 | BATHTUB RAILS | Fred Sammons, Inc. | 1976-12-02 |
| K761129 | CONTOURED RAISED TOILET SEAT | Fred Sammons, Inc. | 1976-12-02 |
| K761127 | LONG HANDLED BATH BRUSH | Fred Sammons, Inc. | 1976-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 44895262521776 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262521362 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262521829 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 24895262521048 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 24895262521390 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 24895262521574 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 24895262521727 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 34895262521304 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 34895262521670 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 34895262521779 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 44895262521578 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 44895262521677 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 44895262521721 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
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| 50822383539978 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2017-05-19 |