INM · Chair, With Casters
Physical Medicine · 21 CFR 890.3100 · Class 1
Overview
| Product Code | INM |
|---|---|
| Device Name | Chair, With Casters |
| Regulation | 21 CFR 890.3100 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063521 | NISSIN PEDIATRIC SERIES WHEELCHAIR | Nissin Medical, Inc. | Feb 5, 2007 | SESE |
| K941738 | STRYKER 5050 STRECHAIR | Stryker Medical | May 6, 1994 | SESE |
| K941569 | CAREMOR CLINER | Winco, Inc. | Apr 26, 1994 | SESE |
| K933000 | RECLINING GERI CHAIRS W/CASTERS & LAP TRAY | Winco, Inc. | Sep 30, 1993 | SESE |
| K926028 | BENCHES | Theradapt Products, Inc. | Mar 24, 1993 | SESE |
| K926054 | ELD-ARONDAK CHAIR | Al'S Woodcraft, Inc. | Mar 22, 1993 | SESE |
| K926053 | ELD-ARONDAK CHAIR | Alert Care, Inc. | Mar 22, 1993 | SESE |
| K926025 | CHAIRS | Theradapt Products, Inc. | Mar 22, 1993 | SESE |
| K925247 | STONEHEART ROLLER AID | Stoneheart, Inc. | Feb 12, 1993 | SESE |
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Kaye Products, Inc. | Feb 12, 1993 | SESE |
| K922045 | SHOWER CHAIRS | Medical Device Inspection Co., Inc. | May 26, 1992 | SESE |
| K921917 | DOLOMITE ROLLATOR | Seamark Technologies | May 26, 1992 | SESE |
| K921752 | AMBULATOR | The Anthros Medical Group | May 4, 1992 | SESE |
| K921817 | RIFTON MOR219 19 & RIFTON MOR225 25 | Rifton Equipment For the Handicapped | Apr 29, 1992 | SESE |
| K913544 | DUKKI | Pin Dot Products, Inc. | Aug 29, 1991 | SESE |
| K895165 | ZIGGY MEDICHAIR | Laszlo Corp. | Sep 11, 1989 | SESE |
| K884760 | SHOWER CHAIR | Linido, Inc. | Nov 30, 1988 | SESE |
| K883309 | MULTI-CARE CHAIR | Mid-Canada Medical | Sep 30, 1988 | SESE |
| K880986 | MECHANICAL WALKER | Canhart Industries, Inc. | Mar 14, 1988 | SESE |
| K862886 | KOOYCHAIR (PEDIATRIC) | Mednet, Inc. | Aug 13, 1986 | SESE |
Top Applicants
- Daun International, Inc. — 2 clearances
- Maddak, Inc. — 2 clearances
- Theradapt Products, Inc. — 2 clearances
- Winco Winfield Co., Inc. — 2 clearances
- Winco, Inc. — 2 clearances
