AccessGUDID - DEVICE: Silk'n (17290015418901)

GUDID

Device Identifier (DI) Information

Brand Name: Silk'n
Version or Model: Relief / HeatLux Pro II
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7290015418904
Company Name: HOME SKINOVATIONS LTD

Primary DI Number: 17290015418901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514891048 *Terms of Use

Device Description: An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

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?
47576	Medium-wave diathermy treatment system generator	A component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152087	000

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 Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e17cb17-efc0-438d-874a-35bf47a01065
Public Version Date: September 28, 2020
Public Version Number: 5
DI Record Publish Date: December 13, 2016