Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021853

FEI Number

6005

Entity Name

FOUR D RUBBER CO LTD

City/State/Country

HEANOR Derbyshire, GB

Establishment Address

Slack Lane, HEANOR Derbyshire DE75 7GX, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FOUR D RUBBER CO LTD (Owner Number: 10029528)

Owner / Operator Contact Address

Slack Lane, HEANOR, GB-DBY DE75 7GX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non Latex Rolyan Band Non Latex EMPI Resistive Exercise Bands Latex Rolyan Energising Tubing Latex Rolyan Energising Exercise Band Non Latex Rolyan Energising Exercise Band Latex Isoband Bands Latex IsoBand Tubing Non Latex Digiband FourD Latex Exercise Band Latex Digiband FourD Non-latex Band Non Latex Rolyan Energising Tubing Latex Rolyan Band Non latex IsoBand Tubing Non Latex IsoBand Band Latex EMPI Resistive Exercise Bands ISOLATE Latex Isotex Oral Barrier Latex ISODAM Polyisoprene Dental Dam Latex BIODAM Non Latex ISODAM Non Latex BIODAM Non Latex IsoTex Oral Barrier

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2009-05-27
EIE	Dam, Rubber	Dental	Class 1	872.6300	2009-05-27
MSC	Barrier, Std, Oral Sex	Obstetrics/Gynecology	Class 2	884.5300	2021-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

FOUR D RUBBER CO 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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021853. Last updated year: 2026. Please use registration number 8021853 when referencing this establishment in official correspondence.