Data / Medical devices / United Kingdom / Ems Physio Ltd.
Ems Physio Ltd.: FDA-registered device maker in Irvine North Ayrshire, United Kingdom, 2 510(k) clearances
Ems Physio Ltd. is registered with the FDA (registration 3004154499) in Irvine North Ayrshire, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 14, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004154499
- Address
- Greig House, Block 1 Annickbank Innovation Campus, Annick Road, Irvine North Ayrshire, United Kingdom, KA11 4LF
- Owner or operator
- EMS PHYSIO LTD. (9063658)
- Roles
- Manufacturer
- First device listed
- April 27, 2007
- Registered through
- 2026
- Brand names listed
- OmniSWD®, Primo Radio Shockwave Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| June 14, 2016 | K153456 | Megapulse III Shortwave Diathermy | IMJ | Substantially Equivalent | Accelerated Care Plus | accessdata.fda.gov |
| January 23, 1998 | K973732 | MEGAPULSE II | IMJ | Substantially Equivalent | Pti | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Updated June 14, 2016. 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.