FDA.reportPublic FDA data

CM-1500 Wrist Cuff

Primary DI
00852670007151
Brand
CM-1500 Wrist Cuff
Company
ZYNEX MEDICAL, INC.
Model
700460
Device description
Wrist Wearable for the use with the CM-1500 cardiac monitoring unit.
Published
2021-01-28
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
DQAOximeter
DSBPlethysmograph, Impedance
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191697000Cardiac Monitor 1500Zynex Medical, Inc.2020-02-21DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852670007151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852670007151008526700071518526700071510852670007151

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorderAn electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-495-6670customersupport@zynex.com

Regulatory Flags#

DUNS number
141582226
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852670007540M-Wave7012002024-03-18
00852670007045E-Wave7002402023-06-07
00852670007007NexWave4004002021-01-28
00852670007038NeuroMove4002752021-01-28
00852670007076Zynex Medical Electrodes3000272018-10-01
00852670007083Zynex Medical Electrodes3000382018-10-01
00852670007090Zynex Medical Electrodes3001172018-10-01
00852670007106Zynex Medical Electrodes1230192018-10-01
00852670007113Zynex Medical Electrodes1230182018-10-01
00852670007021TruWave TENS4004202021-01-28
00852670007052InWave4004102021-01-28

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Primary DI, Brand, Company table
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