INN · Chair, Adjustable, Mechanical
Physical Medicine · 21 CFR 890.3100 · Class 1
Overview
| Product Code | INN |
|---|---|
| Device Name | Chair, Adjustable, Mechanical |
| 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 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945650 | SPIFFY | Thames Valley Children'S Centre | Dec 19, 1994 | SESE |
| K942397 | THERADAPT HIGHCHAIR/STROLLER INSERT | Theradapt Products, Inc. | Jun 22, 1994 | SESE |
| K930520 | THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR | Theradapt Products, Inc. | Mar 24, 1993 | SESE |
| K923753 | ABLE GENERATION THERAPY TILT BENCH | The Able Generation, Inc. | Jan 29, 1993 | SESE |
| K923752 | ABLE GENERATION PLAY CHAIR | The Able Generation, Inc. | Jan 29, 1993 | SESE |
| K923750 | ABLE GENERATION BOOSTER CHAIR | The Able Generation, Inc. | Jan 29, 1993 | SESE |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Kaye Products, Inc. | Jul 21, 1992 | SESE |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | May 26, 1992 | SESE |
| K921272 | ACTIVITY CHAIR | Rifton Equipment For the Handicapped | Apr 7, 1992 | SESE |
| K904069 | BRODA NURSING CARE CHAIR | Broda Ent., Inc. | Sep 17, 1990 | SESE |
| K902951 | SHOWER-A-WAY | Tri-S-Sales and Mfg. | Jul 25, 1990 | SESE |
| K902600 | THE COMPANION NON-ELECTRIC LIFT CHAIR | Innovative Medical Engineering, Inc. | Jun 21, 1990 | SESE |
| K896814 | TOI-LIFT | Mill-Tech Ent., Inc. | Feb 20, 1990 | SESE |
| K894767 | CORNER SEAT | Canadian Posture and Seating Centre, Inc. | Jan 17, 1990 | SESE |
| K882090 | HIP SAVER | Pride Health Care, Inc. | May 26, 1988 | SESE |
| K874060 | CONVERTA-LITTER | Camtec | Dec 10, 1987 | SESE |
| K862957 | MERIVAARA GERIATRIC CHAIR MODEL 455 | Global Medical Prods, Inc. | Aug 21, 1986 | SESE |
| K862885 | CAR SEAT | Mednet, Inc. | Aug 14, 1986 | SESE |
| K862883 | ORTHOPEDIC SEATS | Mednet, Inc. | Aug 14, 1986 | SESE |
| K841691 | SPLIT SEAT POSITIONING CHAIR | Maddak, Inc. | May 9, 1984 | SESE |
Top Applicants
- Kaye Products, Inc. — 3 clearances
- The Able Generation, Inc. — 3 clearances
- Fred Sammons, Inc. — 2 clearances
- Mednet, Inc. — 2 clearances
- Theradapt Products, Inc. — 2 clearances
