KNO · Accessories, Wheelchair
Physical Medicine · 21 CFR 890.3910 · Class 1
Overview
| Product Code | KNO |
|---|---|
| Device Name | Accessories, Wheelchair |
| Regulation | 21 CFR 890.3910 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.
Classification Rationale
Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870298 | REDMAN ACCESSORIES | Redman, Inc. | Feb 26, 1987 | SESE |
| K823646 | FRICTION FEEDER | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823645 | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823816 | WHEELCHAIR PATIENT RESTRAINTS | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823636 | ARM THROUGH FOR WHEELCHAIR BK-6459-01 & | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823635 | CUSHIONS FOR WHEELCHAIR ARMS | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823596 | CLAMP ON HOLDER FOR A GLASS OR CUP | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823595 | HEAD SUPPORT FOR WHEELCHAIR | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K821642 | WHEEL CHAIR ACCESSORIES | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K820964 | WHEELCHAIR PAL | Pryor Products | Apr 16, 1982 | SESE |
| K813627 | BK-6453 RIMMED ACRYLIC LAP TRAY KIT | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K812350 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K811482 | INCONTINENT PAD | Fred Sammons, Inc. | Aug 25, 1981 | SESE |
| K811486 | WHEELCHAIR RAMPS | Fred Sammons, Inc. | Jun 16, 1981 | SESE |
| K811491 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K810448 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K810439 | BODY STRAP | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K801709 | BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF | Fred Sammons, Inc. | Aug 7, 1980 | SESE |
| K801489 | EZ ON SAFETY PONCHO | Skil-Care Corp. | Jul 14, 1980 | SESE |
| K801214 | HAMILTON TUCKAWAY DESK | Orthopedic Systems, Inc. | May 30, 1980 | SESE |
Top Applicants
- Fred Sammons, Inc. — 25 clearances
- Orthopedic Equipment Co., Inc. — 4 clearances
- Skil-Care Corp. — 2 clearances
- Danek Medical, Inc. — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance
