Accessories, Wheelchair
Wheelchair Accessories are supplemental attachments, cushions, trays, bags, and other add-on items designed to enhance the comfort, function, safety, or adaptability of wheelchairs for individuals with mobility impairments. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KNO and the applicable regulation is 21 CFR 890.3910 in the Physical Medicine specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KNO
- Device Class
- FDA class 1
- Regulation Number
- 890.3910
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
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 |
|---|---|---|---|---|
| K870298 | REDMAN ACCESSORIES | Feb 26, 1987 | Substantially Equivalent | Redman, Inc. |
| K823646 | FRICTION FEEDER | Jan 21, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K823645 | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | Jan 21, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K823816 | WHEELCHAIR PATIENT RESTRAINTS | Jan 14, 1983 | Substantially Equivalent | Danek Medical, Inc. |
| K823636 | ARM THROUGH FOR WHEELCHAIR BK-6459-01 & | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823635 | CUSHIONS FOR WHEELCHAIR ARMS | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823596 | CLAMP ON HOLDER FOR A GLASS OR CUP | Dec 22, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823595 | HEAD SUPPORT FOR WHEELCHAIR | Dec 22, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K821642 | WHEEL CHAIR ACCESSORIES | Jun 11, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K820964 | WHEELCHAIR PAL | Apr 16, 1982 | Substantially Equivalent | Pryor Products |
| K813627 | BK-6453 RIMMED ACRYLIC LAP TRAY KIT | Jan 19, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K812350 | WHEELCHAIR ACCESSORIES | Sep 11, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K811482 | INCONTINENT PAD | Aug 25, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K811486 | WHEELCHAIR RAMPS | Jun 16, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K811491 | WHEELCHAIR ACCESSORIES | Jun 12, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K810448 | WHEELCHAIR ACCESSORIES | Mar 04, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K810439 | BODY STRAP | Mar 04, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K801709 | BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF | Aug 07, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K801489 | EZ ON SAFETY PONCHO | Jul 14, 1980 | Substantially Equivalent | Skil-Care Corp. |
| K801214 | HAMILTON TUCKAWAY DESK | May 30, 1980 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K800208 | SKIL-CARE LEG PADS | Feb 21, 1980 | Substantially Equivalent | Skil-Care Corp. |
| K790177 | ASHTRAY FOR WHEELCHAIR | Feb 08, 1979 | Substantially Equivalent | Fred Sammons, Inc. |
| K790176 | ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT | Feb 08, 1979 | Substantially Equivalent | Fred Sammons, Inc. |
| K781203 | TRAY, LAP, MOLDED | Jul 31, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K781202 | VEST, SUPPORT, TRUNK | Jul 31, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K781195 | BAG, WALDER | Jul 31, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K781194 | BAG, WHEELCHAIR | Jul 31, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K780195 | WHEELCHAIR MUFF | Mar 09, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K780194 | TOE LOOPS | Feb 14, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K780193 | HEEL LOOPS | Feb 14, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K780191 | STRAP, LEGREST | Feb 14, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K760296 | ADJUSTER, WHEELCHAIR WIDTH, BK-6470 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K760295 | CARPET COVERS FOR FOOTRESTS, BK-6467 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K760292 | DESK, BEANBAG SHUFFLE, BK-6059 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K760290 | CANE OR CRUTCH PARKER (3/4, 7/8, L) | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 217 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 217 registration numbers. Click on an entry to view related FDA registrations.