Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016774562

FEI Number

3016774562

Entity Name

Whele LLC

City/State/Country

Austin, TX, US

Establishment Address

801 Barton Springs Rd, Austin, TX 78704, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Whele, LLC (Owner Number: 10079252)

Owner / Operator Contact Address

501 Boylston St, 09B133, Boston, MA 02116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Azmed Might Bliss Large or XLarge Heating Pad Madison Supply

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-12-12
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-06-27
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Whele, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016774562. Last updated year: 2026. Please use registration number 3016774562 when referencing this establishment in official correspondence.