OPEN BIONICS

FDA Device Registration & Listing · Bristol Bristol, City of, GB · Registration 3012881757

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012881757
FEI Number
3012881757
Entity Name
OPEN BIONICS
City/State/Country
Bristol Bristol, City of, GB
Establishment Address
Programme, Tower Lane, Bristol Bristol, City of BS1 2NB, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Open Bionics (Owner Number: 10055870)
Owner / Operator Contact Address
Programme, Tower Lane, Bristol, GB-NOTA BS1 2NB, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gripster (weightlifting) Builder Rider (cycling) Swinger (gymnastics) Prana (Yoga, Pushups) Drummer Hero AIR Hero RGD Hero PRO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQX Hook, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2025-02-05
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2017-10-13
IRA Hand, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2024-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Consulting LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Open Bionics
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 3012881757. Last updated year: 2026. Please use registration number 3012881757 when referencing this establishment in official correspondence.
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