Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014083954

FEI Number

3014083954

Entity Name

ACTIVINSIGHTS LTD.

City/State/Country

Kimbolton Cambridgeshire, GB

Establishment Address

6 Nene Road, Bicton Industrial Park, Kimbolton Cambridgeshire PE28 0LF, GB

Establishment Type(s)

Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ActivInsights Ltd. (Owner Number: 10056642)

Owner / Operator Contact Address

6 Nene Road, Bicton Industrial Park, Kimbolton, GB-CAM PE28 0LF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GENEActiv

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	Class 2	890.1925	2018-01-04

Official Correspondent

Richard Thomas

US Agent Details

James Martin Biggs Business: GBM Authorized Representative Ltd. Email: caroline@mba-gbm.com Phone: (405) 7771033

Related Public Records

Same Entity

ActivInsights 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 3014083954. Last updated year: 2026. Please use registration number 3014083954 when referencing this establishment in official correspondence.