INF · Scale, Platform, Wheelchair
Physical Medicine · 21 CFR 890.3940 · Class 1
Overview
| Product Code | INF |
|---|---|
| Device Name | Scale, Platform, Wheelchair |
| Regulation | 21 CFR 890.3940 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A wheelchair platform scale is a device with a base designed to accommodate a wheelchair. It is intended for medical purposes to weigh a person who is confined to a wheelchair.
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. 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | U.S. Medical Corp. | Feb 12, 1993 | SESE |
| K910055 | ACME MODEL 8500 WHEELCHAIR SCALE | Acme Medical Scale Co. | Jan 14, 1991 | SESE |
| K884908 | ULTRAFLOTATION MEDICAL WHEELCHAIR | Medical Flotation Systems, Inc. | Dec 27, 1988 | SESE |
| K871391 | AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) | Amigo Sales, Inc. | May 6, 1987 | SESE |
| K760327 | WHEEL'N WEIGH | Acme Medical Scale Co. | Oct 20, 1976 | SESE |
Top Applicants
- Acme Medical Scale Co. — 2 clearances
- Amigo Sales, Inc. — 1 clearance
- Medical Flotation Systems, Inc. — 1 clearance
- U.S. Medical Corp. — 1 clearance
