AccessGUDID - DEVICE: Soovu Heatwave Therapy (00850014805005)

GUDID

Device Identifier (DI) Information

Brand Name: Soovu Heatwave Therapy
Version or Model: SL-WPTKIT-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Soovu Labs, Inc.

Primary DI Number: 00850014805005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097930553 *Terms of Use

Device Description: Soovu Pain Relief System is a kit branded as Soovu Heatwave Therapy and includes two 2" x 2" pods/heaters that, when adhered to user's skin via disposable adhesive rings, provide pulsed heat at controlled temperatures for set therapy durations. The pods are Bluetooth-paired with, and controlled via, a mobile device application (Soovu on iOS or Android) from which the user also administers the heat therapy sessions. The Soovu Heatwave Therapy Kit includes 2 heating pods, 1 dual-pod charging cradle, 1 USB charging cable, 60 'Daily' adhesives, carry case, and Quick Start Guide.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7ba7ef7-2983-47e4-aecb-bfe903df213c
Public Version Date: December 06, 2022
Public Version Number: 1
DI Record Publish Date: November 28, 2022