Data / Medical devices / China / Chongqing Psk-Health Sci-Tech Development Co., Ltd
Chongqing Psk-Health Sci-Tech Development Co., Ltd: FDA-registered device maker in Chongqing, China, 2 510(k) clearances
Chongqing Psk-Health Sci-Tech Development Co., Ltd is registered with the FDA (registration 3010145926) in Chongqing, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010145926
- Address
- No. 3-2, 4-1, 4-2, 4th Building, Gangcheng Donghuan Road No.5, Jiangbei District, Chongqing, China, 400026
- Owner or operator
- Chongqing PSK-Health Sci-Tech Development CO.,Ltd (10046049)
- Roles
- Manufacturer
- First device listed
- January 28, 2014
- Registered through
- 2026
- Brand names listed
- Air-bag Type Sequential External Counter-pulsation Device,PECP/TI, Air-bag Type Sequential External Counter-pulsation Device,PECP/TM, Lumenair EECP® Therapy System, model Lumenair
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2013 | K130439 | EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING | DRN | Substantially Equivalent | Chongqing Psk Sci-Tech Development Co., Ltd. | accessdata.fda.gov |
| March 1, 2004 | K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | DRN | Substantially Equivalent | Vasomedical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.