Product Code: FRW FDA class 1 21 CFR 880.2720

Scale, Patient

General Hospital

A patient scale is a clinical weighing device used to measure a patient's body weight, supporting ongoing monitoring and medical decision-making in healthcare settings. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRW, regulated under 21 CFR 880.2720, within the General Hospital medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FRW
Device Class: FDA class 1
Regulation Number: 880.2720
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955357	OLYMPIC SMART SCALE MODEL 50/50RA	Jan 30, 1996	Substantially Equivalent	Olympic Medical Corp.
K955177	OLYMPIC SMART SCALE	Dec 14, 1995	Substantially Equivalent	Olympic Medical Corp.
K954846	OLYMPIC SMART SCALE	Dec 14, 1995	Substantially Equivalent	Olympic Medical Corp.
K952649	WARM-SCALE	Aug 15, 1995	Substantially Equivalent	Olympic Medical Corp.
K943587	ADVANCED IN-BED WEIGH SYSTEM	Sep 22, 1994	Substantially Equivalent	Future Systems, Inc.
K932572	DIGITAL BABY SCALE MODEL BLB-12	Nov 16, 1993	Substantially Equivalent	Tanita Corp. of America
K926174	MODEL 9100 H.R. INFANT SCALE	Oct 25, 1993	Substantially Equivalent	Acme Medical Scale Co.
K926446	EZ PUMP	Sep 27, 1993	Substantially Equivalent	Alphamed, Inc.
K926059	3M MODEL 200RT RATE TAPER INFUSION PUMP	Aug 16, 1993	Substantially Equivalent	3M Health Care, Ltd.
K926058	3M MODEL 280RT RATE TAPER INFUSION PUMP	Aug 16, 1993	Substantially Equivalent	3M Health Care, Ltd.
K930626	SANITAS PATIENT SCALE	Aug 06, 1993	Substantially Equivalent	Dutton-Lainson Co.
K920063	DISETRONIC DOLOMAT PUMP	Aug 03, 1993	Substantially Equivalent	Disetronic Medical Systems
K924847	DETECTO MODEL 6700 SERIES	May 24, 1993	Substantially Equivalent	Cardinal Scale Mfg. Co.
K922119	MODEL 5002 LIFT WEIGH-SCALE	Feb 03, 1993	Substantially Equivalent	Acme Medical Scale Co.
K920812	FAIRBANKS BABY SCALE	May 13, 1992	Substantially Equivalent	Fairbanks Scales, Inc.
K920074	ARJO CENTURY SCALES WITH REMOTE	Apr 06, 1992	Substantially Equivalent	Arjo-Century, Inc.
K912662	SCALE-TRONIX PLATFORM SCALE	Mar 27, 1992	Substantially Equivalent	Scale-Tronix, Inc.
K910583	U.S. MEDICAL PS-3000 NEONATAL SCALE	Mar 21, 1991	Substantially Equivalent	U.S. Medical Corp.
K910582	U.S. MEDICAL PS-2000 PEDIATRIC SCALE	Mar 21, 1991	Substantially Equivalent	U.S. Medical Corp.
K910581	U.S. MEDICAL PS-1000 PEDIATRIC SCALE	Mar 21, 1991	Substantially Equivalent	U.S. Medical Corp.
K905122	SENTRY SCALE	Mar 15, 1991	Substantially Equivalent	Apollo Enterprise, Ltd. Co.
K905061	APOLLO MOBILE SCALE	Feb 12, 1991	Substantially Equivalent	Apollo Enterprise, Ltd. Co.
K904138	SMART SCALE X-RAY PLATFORM	Nov 19, 1990	Substantially Equivalent	Olympic Medical Corp.
K904286	SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED	Oct 01, 1990	Substantially Equivalent	Scale-Tronix, Inc.
K902260	SCALE-TRONIX INCUBATOR SCALE MODEL:4050	Aug 14, 1990	Substantially Equivalent	Scale-Tronix, Inc.
K902545	VAAKA BABY SCALE	Jul 26, 1990	Substantially Equivalent	Ferguson Medical
K901522	OLYMPIC SMART SCALE PEDIATRICS MODEL 50	Jun 22, 1990	Substantially Equivalent	Olympic Medical Corp.
K872524	SAFEWEIGH MAGIC SCALE	Oct 09, 1987	Substantially Equivalent	Health Care Innovations, Inc.
K871771	COMFORTWEIGH	Jun 24, 1987	Substantially Equivalent	Curlington Industrial Electronics, Inc.
K871104	OLYMPIC SMART SCALE	May 22, 1987	Substantially Equivalent	Olympic Medical Corp.
K870888	WARM WEIGH MODEL N-10 INFANT SCALE	Mar 17, 1987	Substantially Equivalent	Air-Shields, Inc.
K864327	MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP	Feb 06, 1987	Substantially Equivalent	Medtronic Minimed
K864953	WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE	Jan 21, 1987	Substantially Equivalent	Dittmar and Penn Corp.
K862477	HOYER DIGITAL ELECTRONIC SCALE	Sep 03, 1986	Substantially Equivalent	Ted Hoyer & Co., Inc.
K853475	GRAM-MA NEONATAL SC	Sep 05, 1985	Substantially Equivalent	Kentec Medical, Inc.
K852278	ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400	Jun 07, 1985	Substantially Equivalent	Acme Medical Scale Co.
K852035	HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES	May 29, 1985	Substantially Equivalent	Continental Scale Corp.
K851014	ACME LOW-PROFILE CHAIR SCAL 7300	Mar 27, 1985	Substantially Equivalent	Acme Medical Scale Co.
K841534	ACME DIGITAL INFANT SCALE-30	May 31, 1984	Substantially Equivalent	Acme Medical Scale Co.
K833754	HAMILTON PEDIATRICS SCALE	Jan 11, 1984	Substantially Equivalent	Befour, Inc.
K830317	INFUSION PUMP ACCESS. #60-01-5	Mar 31, 1983	Substantially Equivalent	Windsor Medical, Inc.
K830171	DIGITAL BEDSIDE SCALE #5000	Feb 18, 1983	Substantially Equivalent	Acme Medical Scale Co.
K822135	SECA DIGITAL BABY SCALE 727	Jul 30, 1982	Substantially Equivalent	Seca Corp.
K822043	SECA CHAIR SCALE-721	Jul 28, 1982	Substantially Equivalent	Seca Corp.
K822042	SECA LIGHT WEIGHT BABY SCALE 744	Jul 28, 1982	Substantially Equivalent	Seca Corp.
K791566	MODEL AS* 6C INFUSION PUMP	Nov 13, 1979	Substantially Equivalent	Baxter Healthcare Corp
K781832	SCALE, ACME DIGITAL BEDSIDE	Dec 07, 1978	Substantially Equivalent	Acme Medical Scale Co.
K760545	WEIGHING STATION, MOBILE PATIENT	Nov 12, 1976	Substantially Equivalent	Gaymar Industries, Inc.