Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004154499

FEI Number

3004154499

Entity Name

EMS PHYSIO LTD.

City/State/Country

Irvine North Ayrshire, GB

Establishment Address

Greig House, Block 1 Annickbank Innovation Campus,, Annick Road, Irvine North Ayrshire KA11 4LF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMS PHYSIO LTD. (Owner Number: 9063658)

Owner / Operator Contact Address

Greig House, Block 1 Annickbank Inovation Campus, Annick Road, Irvine, GB-NAY KA11 4LF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OmniSWD® Primo Radio Shockwave Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2016-12-13
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-01-12

Official Correspondent

JOE O'NEILL

US Agent Details

Lee Grasseschi Business: Accelerated Care Plus Email: Lgrasseschi@Hanger.Com Phone: (775) 2231391

Related Public Records

Same Entity

EMS PHYSIO LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004154499. Last updated year: 2026. Please use registration number 3004154499 when referencing this establishment in official correspondence.