KNN · Components, Wheelchair
Physical Medicine · 21 CFR 890.3920 · Class 1
Overview
| Product Code | KNN |
|---|---|
| Device Name | Components, Wheelchair |
| Regulation | 21 CFR 890.3920 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.
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 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | Kinetic Innovative Seating System, LLC | Mar 4, 2022 | SESE |
| K942311 | DYNASTY U1-33 AGM | Foley & Lardner | Nov 7, 1994 | SESE |
| K942310 | DYNASTY GC 12550 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE |
| K942309 | DYNASTY U1-31 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE |
| K942308 | DYNASTY GC 12400 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE |
| K942312 | ALDEN LINEAGE WHEELCHAIR CUSHION | Lewis W. Ward | May 26, 1994 | SESE |
| K942260 | ALDEN WHEELCHAIR CUSHION | Ward and Assoc. | May 26, 1994 | SESE |
| K933051 | ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION | General Components Intl., Inc. | Oct 12, 1993 | SESE |
| K925980 | PM | Pathfinder Intl. Corp. | Mar 24, 1993 | SESE |
| K923942 | RHOMBO MEDICAL RHOMBO-FILL | International Medical Products, Inc. | Mar 24, 1993 | SESE |
| K923364 | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | Labac Systems, Inc. | Mar 22, 1993 | SESE |
| K925336 | VALU-PLUS PAD | Valmed, Inc. | Feb 12, 1993 | SESE |
| K923366 | TILT SEATING SYSTEM | Labac Systems, Inc. | Feb 12, 1993 | SESE |
| K923186 | NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC | Roho, Inc. | Sep 9, 1992 | SESE |
| K921369 | BIOMEDICAL HORIZONS MODEL 1001 | Biomedical Horizons, Inc. | May 11, 1992 | SESE |
| K921027 | MANUAL CHAIR BASE | Labac Systems, Inc. | Mar 20, 1992 | SESE |
| K915629 | CUSHION, WHELCHAR AND FLOTATION | Invacare Corp. | Jan 9, 1992 | SESE |
| K915368 | SERENA WHEELCHAIR CUSHIONS | A & C Medical Supply | Dec 20, 1991 | SESE |
| K913553 | PIN DOT GROWTH/DIAL LINKS | Pin Dot Products, Inc. | Sep 5, 1991 | SESE |
| K913550 | PIN DOT TRUNION MOUNTS | Pin Dot Products, Inc. | Sep 5, 1991 | SESE |
Top Applicants
- Pin Dot Products, Inc. — 10 clearances
- Berkeley Electric Wheelchair Co. — 5 clearances
- Foley & Lardner — 4 clearances
- Fred Sammons, Inc. — 4 clearances
- Rolcontrol Products, Co., Inc. — 4 clearances
