Blood Pressure Meter
The RH Max02 blood pressure meter is a manual aneroid sphygmomanometer for measuring systolic and diastolic blood pressure by listening for Korotkoff sounds. It is intended for medical…
The RH Max02 blood pressure meter is a manual aneroid sphygmomanometer for measuring systolic and diastolic blood pressure by listening for Korotkoff sounds. It is intended for medical professionals or home use, with appropriate cuff selection for the patient.
A hand bulb inflates the cuff, and a valve controls deflation. Tubing connects the cuff to an aneroid gauge with a scale from 0 to 300 mmHg in two mmHg increments.
Listed Item
The Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include additional stethoscope. It is conjunction with Stethoscope when use.
Family Configurations
Max0201, Max0202 and Max0203 configurations include a stethoscope, while Max02 is the blood pressure meter configuration. The family covers infants, children and adults, with the upper arm as the usual measurement site and leg use specified for children.
Who Else Makes It
Concentrated in Guangdong (22), Zhejiang (13), Jiangsu (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| A&D Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Suntech Medical Devices (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shanghai Minhua Medical Apparatus Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Wenzhou Naisi Health Product Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 50. All 50 manufacturers in China registered for Blood Pressure Cuff
Record
| Listed by | Wenzhou Renhua Instruments Co., Ltd., China |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K190902 |
| Record published | 2019-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model Max02 (Blue, Pink or Black cuff) | In distribution | |
| Model Max0203 (Blue, Pink or Black cuff) | In distribution | |
| Model Max0202 (Blue, Pink or Black cuff) | In distribution | |
| Model Max0201 (Blue, Pink or Black cuff) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 1,801 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,310 |
| Diagnostix™ | American Diagnostic Corp. | 681 |
| Orantech | Orantech Inc. | 648 |
| Blood Pressure Cuff | Salter Labs | 425 |
| Aneroids (82 etc.) | Rashman Corp. | 418 |
| Medline | Medline Industries, Inc. | 390 |
| Baum | W.A. Baum Co., Inc. | 349 |
| Adcuff™ | American Diagnostic Corp. | 348 |
| Disposable cuff | Suntech Medical, Inc. | 326 |
| Vistarmed | Shenzhen Vistar Medical Supplies Co., Ltd. | 254 |
| Statcorp Medical | Statcorp, Inc. | 229 |
Showing 12 of 598. All products under Blood Pressure Cuff
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190902 | 2019-05-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.