FDA.reportPublic FDA data

BlackBox

Primary DI
B963WS501C0
Brand
BlackBox
Company
Blackbox Remote Patient Monitoring LLC
Model
WS-501C
Device description
Cellular weight scale with a large platform and high weight capacity
Published
2022-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRWScale, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
BB4B963WS501C1PackageHIBCC4In Commercial Distribution
B963WS501C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Contacts#

Phone, Email table
PhoneEmail
4355129587Jared@BlackBoxRPM.com

Regulatory Flags#

DUNS number
117652799
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B963103C0BlackBox RPMBPM-103C2025-01-01
BB4B963WS501C1BlackBoxWS-501C2022-07-27
B963PO401W1BlackBox RPMPO-401W2020-10-20
B963102C1BlackBox RPMBPM-102C2021-08-01
B963BPM201W1BlackBox RPMBPM-201W2020-10-12
BB4B963PO401W1BlackBox RPMPO-401W2020-10-20
B963101C1BlackBoxBPM-101C2020-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030022927seca 406seca GmbH & Co. KGFRW2026-04-22
H933P11634Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FRW2025-12-03
04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
04719846016040CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
40080196291237MEDLINEMEDLINE INDUSTRIES, INC.FRW2025-06-25
00860012873609WoddleWoddle Baby, Inc.FRW2025-06-02
10688503001051SavariaSavaria Concord LiftFRW2025-05-29
10688503001068SavariaSavaria Concord LiftFRW2025-05-29
00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28
00628725008271SMART SCALECanadian Hospital Specialties LimitedFRW2025-02-28
00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16
04012030003711seca 206seca GmbH & Co. KGFRW2024-10-01
04012030003759seca 212seca GmbH & Co. KGFRW2024-10-01
04012030004381seca 206seca GmbH & Co. KGFRW2024-10-01
04012030007252seca 201seca GmbH & Co. KGFRW2024-10-01
04012030007269seca 201seca GmbH & Co. KGFRW2024-10-01
14012030003718seca 206seca GmbH & Co. KGFRW2024-10-01
14012030003756seca 212seca GmbH & Co. KGFRW2024-10-01
24012030004385seca 206seca GmbH & Co. KGFRW2024-10-01
14012030007259seca 201seca GmbH & Co. KGFRW2024-10-01
24012030007263seca 201seca GmbH & Co. KGFRW2024-10-01
05600494138736WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUSINVACARE CORPORATIONFRW2024-08-15
00732094251050Welch Allyn, Inc.WELCH ALLYN, INC.FRW2024-08-14
04012030021081seca 442seca GmbH & Co. KGFRW2024-05-07
04012030021470seca 495seca GmbH & Co. KGFRW2024-05-01
04012030021487seca 495 rseca GmbH & Co. KGFRW2024-05-01
04012030021494seca 496seca GmbH & Co. KGFRW2024-05-01
04012030021500seca 604seca GmbH & Co. KGFRW2024-05-01
04012030021593seca 404seca GmbH & Co. KGFRW2024-05-01
04012030021609seca 446seca GmbH & Co. KGFRW2024-05-01