LFF · Unit, Activation, Breath Control
Physical Medicine · 21 CFR 890.3920 · Class 1
Overview
| Product Code | LFF |
|---|---|
| Device Name | Unit, Activation, Breath Control |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964977 | IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) | Interactive Living Systems, Inc. | Aug 31, 1998 | SESE |
Top Applicants
- Interactive Living Systems, Inc. — 1 clearance
