AccessGUDID - DEVICE: KT RECOVERY+ WAVE (00851329005463)

GUDID

Device Identifier (DI) Information

Brand Name: KT RECOVERY+ WAVE
Version or Model: 088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-KT
Company Name: Bioelectronics Corporation

Primary DI Number: 00851329005463
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2031
Device Count: 1
Labeler D-U-N-S® Number*: 101591571 *Terms of Use

Device Description: KT RECOVERY+ WAVE Electromagnetic Pain Relief

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:	No
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?
35169	Hand-held deep-tissue electromagnetic stimulator	A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQY	Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fcca966-12f6-4a15-a8ce-def3d1655ab6
Public Version Date: March 11, 2021
Public Version Number: 1
DI Record Publish Date: March 03, 2021