Product Code: INM
FDA class 1
21 CFR 890.3100
Chair, With Casters
Physical Medicine
A Chair with Casters is a mobile seating device used in Physical Medicine and clinical environments that incorporates caster wheels to allow repositioning of the patient or chair without lifting, supporting patient comfort and clinical workflow in rehabilitation and hospital settings. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is INM, regulated under 21 CFR 890.3100, within the Physical Medicine medical specialty.
510(k)s
35
FEI Numbers
186
Registration Numbers
186
Unique Applicants
30
Years Active
29
Basic Information
- Product Code
- INM
- Device Class
- FDA class 1
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 35 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K063521 | NISSIN PEDIATRIC SERIES WHEELCHAIR | Feb 05, 2007 | Substantially Equivalent | NISSIN MEDICAL INC. |
| K941738 | STRYKER 5050 STRECHAIR | May 06, 1994 | Substantially Equivalent | STRYKER MEDICAL |
| K941569 | CAREMOR CLINER | Apr 26, 1994 | Substantially Equivalent | WINCO, INC. |
| K933000 | RECLINING GERI CHAIRS W/CASTERS & LAP TRAY | Sep 30, 1993 | Substantially Equivalent | WINCO, INC. |
| K926028 | BENCHES | Mar 24, 1993 | Substantially Equivalent | THERADAPT PRODUCTS, INC. |
| K926054 | ELD-ARONDAK CHAIR | Mar 22, 1993 | Substantially Equivalent | AL'S WOODCRAFT, INC. |
| K926053 | ELD-ARONDAK CHAIR | Mar 22, 1993 | Substantially Equivalent | ALERT CARE, INC. |
| K926025 | CHAIRS | Mar 22, 1993 | Substantially Equivalent | THERADAPT PRODUCTS, INC. |
| K925247 | STONEHEART ROLLER AID | Feb 12, 1993 | Substantially Equivalent | STONEHEART, INC. |
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Feb 12, 1993 | Substantially Equivalent | KAYE PRODUCTS, INC. |
| K922045 | SHOWER CHAIRS | May 26, 1992 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K921917 | DOLOMITE ROLLATOR | May 26, 1992 | Substantially Equivalent | SEAMARK TECHNOLOGIES |
| K921752 | AMBULATOR | May 04, 1992 | Substantially Equivalent | THE ANTHROS MEDICAL GROUP |
| K921817 | RIFTON MOR219 19 & RIFTON MOR225 25 | Apr 29, 1992 | Substantially Equivalent | RIFTON EQUIPMENT FOR THE HANDICAPPED |
| K913544 | DUKKI | Aug 29, 1991 | Substantially Equivalent | PIN DOT PRODUCTS, INC. |
| K895165 | ZIGGY MEDICHAIR | Sep 11, 1989 | Substantially Equivalent | LASZLO CORP. |
| K884760 | SHOWER CHAIR | Nov 30, 1988 | Substantially Equivalent | LINIDO, INC. |
| K883309 | MULTI-CARE CHAIR | Sep 30, 1988 | Substantially Equivalent | MID-CANADA MEDICAL |
| K880986 | MECHANICAL WALKER | Mar 14, 1988 | Substantially Equivalent | CANHART INDUSTRIES, INC. |
| K862886 | KOOYCHAIR (PEDIATRIC) | Aug 13, 1986 | Substantially Equivalent | MEDNET, INC. |
| K851550 | MERIVAARA GERIATRIC CHAIR | Jul 09, 1985 | Substantially Equivalent | DAUN INTERNATIONAL, INC. |
| K851548 | AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS | Jul 09, 1985 | Substantially Equivalent | DAUN INTERNATIONAL, INC. |
| K841194 | MEDICAL CHAIR, MULTIPURPOSE TAST SUPPORT | May 30, 1984 | Substantially Equivalent | NEUTRAL POS-CHAIR CO. |
| K841911 | ALPHA PUSH KART | May 23, 1984 | Substantially Equivalent | ALPHA UNLIMITED, INC. |
| K841700 | WALK & ROLL | May 11, 1984 | Substantially Equivalent | MADDAK, INC. |
| K841725 | OSLO ARMCHAIR | May 09, 1984 | Substantially Equivalent | MONDIAL, INC. |
| K840638 | PORTABLE TRANSIT CHAIR | Mar 16, 1984 | Substantially Equivalent | POIRIER S.A. |
| K830850 | OB TRIPP TRANSPORT CHAIR | Apr 05, 1983 | Substantially Equivalent | LIC-ORTHION |
| K823151 | OB TRIPP TRANSPORT CHAIR | Nov 05, 1982 | Substantially Equivalent | ORTHION CORP. |
| K822992 | PEOPLE MOVER | Oct 27, 1982 | Substantially Equivalent | CONVAID PRODUCTS, INC. |
| K820858 | ESCORT | Apr 08, 1982 | Substantially Equivalent | AMIGO SALES, INC. |
| K802745 | FOLDING SHOWER-COMMODE CHAIR | Nov 19, 1980 | Substantially Equivalent | WINCO WINFIELD CO., INC. |
| K802744 | FOLDING ROLL-ABOUT CHAIR | Nov 19, 1980 | Substantially Equivalent | WINCO WINFIELD CO., INC. |
| K790560 | ROLLCHAIR, ORTHO BUCKET SEAT | Apr 10, 1979 | Substantially Equivalent | MADDAK, INC. |
| K781001 | CHAIRS WITH CASTORS | Jun 30, 1978 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
FEI Numbers
This FDA classification entry is associated with 186 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 186 registration numbers. Click on an entry to view related FDA registrations.