Data / Medical devices / United States / Pulsar Scientific, LLC
Pulsar Scientific, LLC: FDA-registered device maker in Ludlow, MA, United States, 2 510(k) clearances
Pulsar Scientific, LLC is registered with the FDA (registration 3010256111) in Ludlow, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010256111
- Address
- 8 Stony Brook St, Ludlow, MA, United States, 01056
- Owner or operator
- Pulsar Scientific, LLC (10081867)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 21, 2021
- Registered through
- 2026
- Brand names listed
- Eliteflexx, Pulsar Flow, Pulsar Recovery + and DVTherapy, ReGenElite Wearable Magnetotherapy Model 40140, Recovery+ and DVTherapy
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | 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 |
|---|---|---|---|---|---|---|
| April 2, 2021 | K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | JOW | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 23, 2011 | K111748 | RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A | JOW | Substantially Equivalent | Joy Long | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2021. 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.