Data / Medical devices / Singapore / Renew Group Private Limited
Renew Group Private Limited: FDA-registered device maker in Singapore Central Singapore, Singapore, 2 510(k) clearances
Renew Group Private Limited is registered with the FDA (registration 3010564728) in Singapore Central Singapore, Singapore. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010564728
- Address
- 463 Macpherson Road, Singapore Central Singapore, Singapore, 368181
- Owner or operator
- RENEW GROUP PRIVATE LIMITED (10046125)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- February 5, 2014
- Registered through
- 2026
- Brand names listed
- ACS Model NCP-2 External Counterpulsation Device, Renew NCP-5 External Counterpulsation System, renew NCP-4 External Counterpulsation Device, renew Treatment Table (TT-1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair And Table, Medical | KMN | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Device, Counter-Pulsating, External | DRN | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 17, 2015 | K152115 | Renew NCP-5 External Counterpulsation System | DRN | Substantially Equivalent | Stage 2 Innovations | accessdata.fda.gov |
| December 9, 2004 | K042413 | ACS MODEL NCP-2 | DRN | Substantially Equivalent | Applied Cardiac Systems | accessdata.fda.gov |
Compare with other makers
Updated December 17, 2015. 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.