Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017140415

FEI Number

3017140415

Entity Name

INITIA, LTD.

City/State/Country

Petah Tikva Central, IL

Establishment Address

10 Nevatim Str., Petah Tikva Central 4956106, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Initia, Ltd. (Owner Number: 10075838)

Owner / Operator Contact Address

10 Nevatim Str., Petah Tikva, Central, 4956106, ISRAEL, Petah Tikva, IL-TA 4956106, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Integra Integra SL Magna MoreNova PRO (10-MPRB-000) MoreNova DT (10-MRNV-000)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2020-06-28
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2020-06-28
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2020-06-28
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: FDAbasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Initia, Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043496871	Regenerative Medical Group Ltd	Harrow, GB

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1061158	STORZ MEDICAL AMERICA, INC.	Kennesaw, GA, US
9613347	STORZ MEDICAL AG	TAEGERWILEN Thurgau, CH
9611388	DORNIER MEDTECH GMBH	WESSLING Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017140415. Last updated year: 2026. Please use registration number 3017140415 when referencing this establishment in official correspondence.