Skip to content

HotDog Temperature Management System WC71

by Augustine Temperature Management, LLC

HotDog Temperature Management System WC71 is a Class II device made by Augustine Temperature Management, LLC, cleared under FDA 510(k) K201779 on 11 Sep 2020 and listed in FDA GUDID since 17 May 2022 (UDI-DI 00850011479018), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K201779

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850011479018 UDI-DI Date17 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK201779 Date11 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201779 decided 11 Sep 2020 Active
  • FDA GUDID UDI-DI 00850011479018 listed 17 May 2022 Listed

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0700-2025 FDA Class II initiated 4 Dec 2024
    • Ongoing Z-0702-2025 FDA Class II initiated 4 Dec 2024
    • Ongoing Z-0701-2025 FDA Class II initiated 4 Dec 2024

    Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

    • Completed Z-0839-2025 FDA Class II initiated 14 Mar 2022

    HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Timeline

6 dated events

  1. Cleared FDA 510(k) K201779
  2. Recall initiated FDA recalls Z-0839-2025
  3. Listed FDA GUDID 00850011479018
  4. Recall initiated FDA recalls Z-0700-2025
  5. Recall initiated FDA recalls Z-0702-2025
  6. Recall initiated FDA recalls Z-0701-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HotDog Temperature Management System
Generic name
Electric pad whole-body heating system
Model / Ref / Catalog
WC71
Primary DI / UDI-DI
00850011479018
510(k) Number
FDA product code
DWJ
GMDN term
Electric pad whole-body heating system
Device class
Class II
Regulation number
870.5900
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Learn More >

Related devices

Category: Electric pad whole-body heating system

Cleared under the same submission (K201779)

Similar devices

Other devices filed under FDA product code DWJ (System, Thermal Regulating).

Other devices from Augustine Temperature Management, LLC

See all devices from Augustine Temperature Management, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)