FRW · Scale, Patient
General Hospital · 21 CFR 880.2720 · Class 1
Overview
| Product Code | FRW |
|---|---|
| Device Name | Scale, Patient |
| Regulation | 21 CFR 880.2720 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices placed under a bed or chair to weigh both the support and the patient, devices where the patient is lifted by a sling from a bed to be weighed, and devices where the patient is placed on the scale platform to be weighed. The device may be mechanical, battery powered, or AC-powered and may include transducers, electronic signal amplification, conditioning and display equipment.
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 § 880.9.
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | Olympic Medical Corp. | Jan 30, 1996 | SESE |
| K955177 | OLYMPIC SMART SCALE | Olympic Medical Corp. | Dec 14, 1995 | SESE |
| K954846 | OLYMPIC SMART SCALE | Olympic Medical Corp. | Dec 14, 1995 | SESE |
| K952649 | WARM-SCALE | Olympic Medical Corp. | Aug 15, 1995 | SESE |
| K943587 | ADVANCED IN-BED WEIGH SYSTEM | Future Systems, Inc. | Sep 22, 1994 | SESE |
| K932572 | DIGITAL BABY SCALE MODEL BLB-12 | Tanita Corp. of America | Nov 16, 1993 | SESE |
| K926174 | MODEL 9100 H.R. INFANT SCALE | Acme Medical Scale Co. | Oct 25, 1993 | SESE |
| K926446 | EZ PUMP | Alphamed, Inc. | Sep 27, 1993 | SESE |
| K926059 | 3M MODEL 200RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | Aug 16, 1993 | SESE |
| K926058 | 3M MODEL 280RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | Aug 16, 1993 | SESE |
| K930626 | SANITAS PATIENT SCALE | Dutton-Lainson Co. | Aug 6, 1993 | SESE |
| K920063 | DISETRONIC DOLOMAT PUMP | Disetronic Medical Systems | Aug 3, 1993 | SESE |
| K924847 | DETECTO MODEL 6700 SERIES | Cardinal Scale Mfg. Co. | May 24, 1993 | SESE |
| K922119 | MODEL 5002 LIFT WEIGH-SCALE | Acme Medical Scale Co. | Feb 3, 1993 | SESE |
| K920812 | FAIRBANKS BABY SCALE | Fairbanks Scales, Inc. | May 13, 1992 | SESE |
| K920074 | ARJO CENTURY SCALES WITH REMOTE | Arjo-Century, Inc. | Apr 6, 1992 | SESE |
| K912662 | SCALE-TRONIX PLATFORM SCALE | Scale-Tronix, Inc. | Mar 27, 1992 | SESE |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | U.S. Medical Corp. | Mar 21, 1991 | SESE |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | U.S. Medical Corp. | Mar 21, 1991 | SESE |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | U.S. Medical Corp. | Mar 21, 1991 | SESE |
Top Applicants
- Acme Medical Scale Co. — 7 clearances
- Olympic Medical Corp. — 7 clearances
- Scale-Tronix, Inc. — 3 clearances
- Seca Corp. — 3 clearances
- U.S. Medical Corp. — 3 clearances
