Prosphyg™
PROSPHYG Aneroid Sphyg, Dlx Cs,Adult, Camouflage, KOI PL, LF
50manufacturers in China registered for this device type
30catalogue numbers in this listing
1510(k) clearance
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 | American Diagnostic Corp., United States |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2017-03-10 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 15 to 85 % RH; Storage environment temperature -4 to 131 °F |
| Packaging | Master case of 14, master case of 20, master case of 10, master case of 12, mastercase of 10, master case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 779-670-11ABKKIT | Adult, 23-40cm | In distribution |
| 760-11ABCAAQ | Adult, 23-40cm | In distribution |
| 775GPK-N | Small Adult(19-27cm), Adult(23-40cm), Large Adult(34-50cm) | In distribution |
| 775-11ANPH | Adult, 23-40cm | In distribution |
| 768-11ACMKOI | Adult, 23-40cm | In distribution |
| 760-11ATDQ | Adult, 23-40cm | In distribution |
| 760-11AGF | Adult, 23-40cm | In distribution |
| 776-670-11ANFE | Adult, 23-40cm | In distribution |
| 760-11APCKOIQ | Adult, 23-40cm | In distribution |
| 760-11AVQ | Adult, 23-40cm | In distribution |
| 768-609-11AV | Adult, 23-40cm | In distribution |
| 768-609-11ARB | Adult, 23-40cm | In distribution |
| 760-11ATD | Adult, 23-40cm | In distribution |
| 775-670BKZDM | Adult, 23-40cm | In distribution |
| 760-11AWCQ | Adult, 23-40cm | In distribution |
| 760-11ATKKOIQ | Adult, 23-40cm | In distribution |
| 768-609-11ATL | Adult, 23-40cm | In distribution |
| 760-11ALPQ | Adult, 23-40cm | In distribution |
| 760-11AWC | Adult, 23-40cm | In distribution |
| 760-11ADV | Adult, 23-40cm | In distribution |
| 760-11AGFQ | Adult, 23-40cm | In distribution |
| 760-11APWP | Adult, 23-40cm | In distribution |
| 760-11ALP | Adult, 23-40cm | In distribution |
| 760-11ABTBQ | Adult, 23-40cm | In distribution |
| 760-11ALEOKOIQ | Adult, 23-40cm | In distribution |
| 760-11APWPQ | Adult, 23-40cm | In distribution |
| 760-11ABTB | Adult, 23-40cm | In distribution |
| 779-670-11AMKIT | Centimeter | In distribution |
| 768-11ATKKOI | Adult, 23-40cm | In distribution |
| 760-11ABKAC | Adult, 23-40cm | 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 |
|---|---|
| K962655 | 1997-01-27 |
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.