Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089870

FEI Number

3030089870

Entity Name

GYROGEAR LIMITED

City/State/Country

Berkhamsted Hertfordshire, GB

Establishment Address

90A High Street, Berkhamsted Hertfordshire HP4 2BL, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GyroGear Limited (Owner Number: 10089356)

Owner / Operator Contact Address

90A High Street, Berkhamsted, GB-HRT HP4 2BL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GyroGlove Right Large - Dual Battery and Dual Harness GyroGlove Left Extra Large GyroGlove Left Large - Dual Battery and Dual Harness GyroGlove Left Extra Large - Dual Battery and Dual Harness GyroGlove - Large Right GyroGlove - Medium Right GyroGlove - Large Left GyroGlove - Medium Left GyroGlove - Small Right GyroGlove Left Medium - Dual Battery and Dual Harness GyroGlove Right Medium - Dual Battery and Dual Harness GyroGlove Right Small - Dual Battery and Dual Harness GyroGlove Right Extra Large - Dual Battery and Dual Harness GyroGlove Left Small - Dual Battery and Dual Harness GyroGlove Right Extra Large GyroGlove - Small Left

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Physical Medicine	Class 1	890.3420	2023-11-30

Official Correspondent

John Piontkowski

US Agent Details

John Piontkowski Business: GyroGear LLC Email: john@gyrogear.net Phone: (612) 9285492

Related Public Records

Same Entity

GyroGear Limited

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 3030089870. Last updated year: 2026. Please use registration number 3030089870 when referencing this establishment in official correspondence.