FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WowGoHealth
DI: 04719878120012
·
Model: Blood Pressure Monitor LS802-B
·
GOLDEN SMART HOME TECHNOLOGY CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WowGoHealth
- Primary DI
- 04719878120012
- Version / Model
- Blood Pressure Monitor LS802-B
- Company Name
- GOLDEN SMART HOME TECHNOLOGY CORP.
- Labeler DUNS
- 656002163
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-18
- Public Version
- 3
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 04da1899-28ad-4b93-93fa-9c8fce0167d1
- Distribution End Date
- 2019-05-17
Device Description
The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). This device detects the appearance of irregular heartbeats during measurement and give a warning signal with readings. The LS802-B is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. LS802-B embed a Bluetooth module that allows it to connect with nearby BT receiving terminal.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719878120012 | GS1 |
Customer Contacts
- Phone
- +88635770693
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131395 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 60 | Millimeter | |
| Width | 110 | Millimeter | |
| Length | 138 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 105 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius