FDA.reportPublic FDA data

BlackBox

Primary DI
BB4B963WS501C1
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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4355129587Jared@BlackBoxRPM.com

Regulatory Flags#

DUNS number
117652799
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B963103C0BlackBox RPMBPM-103C2025-01-01
B963WS501C0BlackBoxWS-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