Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055581

FEI Number

1000113231

Entity Name

ANODYNE THERAPY, LLC

City/State/Country

Oldsmar, FL, US

Establishment Address

301B Mears Blvd, Oldsmar, FL 34677, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANODYNE THERAPY, LLC (Owner Number: 9004867)

Owner / Operator Contact Address

301B Mears Blvd, --, Oldsmar, FL 34677, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ANODYNE THERAPY SYSTEM Heating Pad

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	2005-10-26
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2008-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANODYNE THERAPY, LLC

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

Similar Registrations

Registration Number	Establishment Name	Location
3016214547	RED DOT LED LIGHTING LIMITED	Shenzhen Guangdong, CN
3014296246	PHOTON THERAPY SYSTEMS (PTY) LTD	Pretoria Gauteng, ZA
3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
3015466811	REV-MED INC.	Yongin-si Gyeonggi, KR
3035879449	DONGGUAN JIAYU ELECTRICAL CO.,LTD	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055581. Last updated year: 2026. Please use registration number 1055581 when referencing this establishment in official correspondence.