Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016472144

FEI Number

3016472144

Entity Name

MEDELLA HEALTH LTD

City/State/Country

Tauranga Bay of Plenty, NZ

Establishment Address

7/144 Third Ave, Tauranga Bay of Plenty 3110, NZ

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medella Health Ltd (Owner Number: 10090693)

Owner / Operator Contact Address

7/144 Third Ave, Tauranga, NZ-BOP 3110, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223729

PMA Number

N/A

All Registered Proprietary Names

Flowpresso

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-04-29

Official Correspondent

Desiree De Spong

US Agent Details

Freddie Kimmel Email: freddie@flowpressousa.com Phone: (917) 6646364

Related Public Records

Same Entity

Medella Health Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

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3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3002849858	CERAGEM CO., LTD.	Cheonan-si, Seobuk-gu Chungnam, KR
3012386142	Therabody, Inc.	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016472144. Last updated year: 2026. Please use registration number 3016472144 when referencing this establishment in official correspondence.