Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033590685

FEI Number

3033590685

Entity Name

BLUBLOX PTY LTD

City/State/Country

Stirling, Vincent Western Australia, AU

Establishment Address

2/40 King Edward Road, Osborne Park, Stirling, Vincent Western Australia 6017, AU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BLUblox Pty Ltd (Owner Number: 10091860)

Owner / Operator Contact Address

2/40 King Edward Road, Osborne Park, Stirling, Vincent, AU-WA 6017, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Red Light Therapy Device (Model: Bullet, Mini, Demi, Max, Super Max, Face Mask, Neck and Chest Mask, Face Wand, Blanket) Lamp Infrared Therapeutic Heating (Model: Red Light Face Mask, Red Light Neck and Chest Mask, Red Light Therapy Blanket) Bullet red light therapy device (Model: TL09(Bullet)) Lamp Infrared Therapeutic Heating (Model: Super Max Red Light Therapy Device) Lamp Infrared Therapeutic Heating (Model: Demi Red Light Therapy Device, Max Red Light Therapy Device) Lamp Infrared Therapeutic Heating (Model: Mini Red Light Therapy Device, Red Light Face Wand) Infrared PEMF Mat (Model: Mini, Demi, Max, Wrap) Infrared Sauna Blanket (Model: Infrared Sauna Blanket)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-11-08
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-11-25

Official Correspondent

Andrew Mant

US Agent Details

Clare Ho Business: SHARE INFO INC Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

BLUblox Pty 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033590685. Last updated year: 2026. Please use registration number 3033590685 when referencing this establishment in official correspondence.