FDA.reportPublic FDA data

ZONN

Primary DI
06975188961136
Brand
ZONN
Company
Zonnsmart Science & Technology Co.,Ltd
Model
HL711 PRO MAX
Device description
This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975188961136PackageGS18In Commercial Distribution
06975188960139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975188961136069751889611366975188961136
06975188960139069751889601396975188960139

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
714639269
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975188960061ZONNHL700 PRO 2024-09-10
06975188960078ZONNHL850 PRO MAX2024-09-10
06975188960085ZONNHL850 PRO2024-09-10
06975188960092ZONNHL880 PRO MAX2024-09-10
06975188960108ZONNHL800 PRO 2024-09-10
06975188960115ZONNHL811 PRO MAX2024-09-10
06975188960122ZONNHL811 PRO2024-09-10
06975188960139ZONNHL711 PRO MAX2024-09-10
06975188960146ZONNHL711 PRO2024-09-10
06975188960054ZONNHL700 PRO MAX2024-09-10
06975188961068ZONNHL700 PRO 2024-09-10
06975188961075ZONNHL850 PRO MAX2024-09-10
06975188961082ZONNHL850 PRO2024-09-10
06975188961099ZONNHL880 PRO MAX2024-09-10
06975188961105ZONNHL800 PRO 2024-09-10
06975188961112ZONNHL811 PRO MAX2024-09-10
06975188961129ZONNHL811 PRO2024-09-10
06975188961143ZONNHL711 PRO2024-09-10
06975188960016ZONNHL8002024-08-27
06975188960023ZONNHL800-BT 2024-08-27

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