FDA.reportPublic FDA data

WVSM Wireless Vital Signs Monitor

Primary DI
B3945000034040
Brand
WVSM Wireless Vital Signs Monitor
Company
ATHENA GTX, INC.
Model
WVSM RWC + miniCap
Catalog number
500-0034-04
Device description
Wireless Patient Monitor
Published
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191989000WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx2020-01-29MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3945000034040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software; typically it incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
515-288-3360info@athenagtx.com

Regulatory Flags#

DUNS number
048031913
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Charger406-0056-012026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Power Cord467-0047-012026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro500-0030-012026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Temperature Probe Adapter Cable530-0046-012026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 12-Lead530-0054-012026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 5-Lead530-0054-022026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo Mainstream (with Ferrite)560-0013-022026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 1' (Dual male connectors)570-0048-012026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 2' (Dual male connectors)570-0048-022026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 3' (Dual male connectors)570-0048-032026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 4' (Dual male connectors)570-0048-042026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 5' (Dual male connectors)570-0048-052026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 6' (Dual male connectors)570-0048-062026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 7' (Dual male connectors)570-0048-072026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 8' (Dual male connectors)570-0048-082026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 9' (Dual male connectors)570-0048-092026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 10' (Dual male connectors)570-0048-102026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Fingerclip extension (with Ferrite)570-0051-022026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Xpod570-0063-012026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo uSpO2570-0064-012026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01
00885403529644Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403529651Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403533191Acumen IQ PlusBecton, Dickinson And CompanyDXN2026-07-31
00885403533207VitaWaveBecton, Dickinson And CompanyDXN2026-07-31
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529668Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529774ClearSight JrBecton, Dickinson And CompanyDXN2026-07-29
00885403529781ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529828VitaWaveBecton, Dickinson And CompanyDXN2026-07-29
00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21