FDA.reportPublic FDA data

Pro Health Mini: Talking Blood Pressure Monitor

Primary DI
10850632007260
Brand
Pro Health Mini: Talking Blood Pressure Monitor
Company
HOME AIDE DIAGNOSTICS, INC.
Model
7263
Device description
Arm-type fully automatic digital blood pressure monitor. LCD digital display. Oscillometric measurement method. 0mmHg~300mmHg pressure range. 30-180 Beats/Minute. 3mmHg pressure accuracy. 5% pulse accuracy. Automatic Pressurization. 120 Memories in Four groups with date and time. low battery detection. Automatic Power-off. 4 AA batteries. Approximately 2 months at 3 test per day battery life. 22.0cm ~36.0cm (8.6" ~14.2") cuff cirfumference.
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191894000Upper Arm Blood Pressure MonitorShenzhen Zhengkang Technology Co., Ltd.2020-02-21DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007260PackageGS130In Commercial Distribution
00850632007263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200726010850632007260
00850632007263008506320072638506320072630850632007263

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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