Shower Trolley
FDA 510(k) K841395 · Setma, Inc.
510(k) numberK841395
Submission
- Device name
- Shower Trolley
- Applicant
- Setma, Inc.
Mchenry, IL, US - Received
- April 3, 1984
- Decision date
- May 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5510
- Specialty
- General Hospital
Other 510(k)s with product code FSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942807 | Surgical Lift SheetFSA · Traditional | Surgin Surgical Instrumentation, Inc. | 08/02/1994SE |
| K930625 | Sanitas Patient LiftFSA · Traditional | Dutton-Lainson Co. | 09/13/1993SE |
| K902141 | Anolift - Portable & Anolift - GantryFSA · Traditional | Anodyne Corp. | 09/12/1990SE |
| K860837 | Hoyer One-Touch Power LifterFSA · Traditional | Ted Hoyer & Co., Inc. | 03/27/1986SE |
| K851844 | MoliftFSA · Traditional | Madshus A/S | 05/17/1985SE |
| K844976 | Medi-Man Water Powered Bath Lift & Hydraulic LiftFSA · Traditional | Medi-Man Rehabilitation Products, Inc. | 04/01/1985SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | Setma, Inc. | 05/07/1984SE |
| K840997 | Battery Powered Patient LiftFSA · Traditional | Invacare Corp. | 04/17/1984SE |
| K823206 | Martin Pelvic LiftFSA · Traditional | Martin Pelvic Lift Co. | 04/28/1983SE |
| K811899 | Century Lift Transfer SystemFSA · Traditional | Century Manufacturing Co. | 07/23/1981SE |
More from Century Manufacturing Co.
| 510(k) | Device | Decision |
|---|---|---|
| K854861 | Setma Hygia Bath Model ST 7200ILJ · Traditional | 01/03/1986SE |
| K854263 | Setma FHT, Model ST 8130ILJ · Traditional | 11/13/1985SE |
| K853163 | Setma VHTILJ · Traditional | 11/05/1985SE |
| K841397 | Burn BathILJ · Traditional | 05/18/1984SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | 05/07/1984SE |
| K841396 | Transfer TrolleyFDA · Traditional | 05/07/1984SE |
Questions and answers
When was Shower Trolley cleared by the FDA?
Shower Trolley (K841395) received a 510(k) decision of Substantially Equivalent on May 7, 1984, 34 days after the submission was received.
What is the product code of K841395?
The FDA product code is FSA – Lift, Patient, Non-Ac-Powered, a Class I (low risk) device regulated under 21 CFR 880.5510.