FDA.reportPublic FDA data

PREMIO 10 MOXA

Primary DI
03760262493107
Brand
PREMIO 10 MOXA
Company
SEDATELEC
Model
PREMIO 10
Catalog number
111237
Device description
The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following:• A handpiece with a Power Supply (110-240V~ /50-60Hz)• A tip concentrator• An user manual• A cover of arrangementThe PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101267000PREMIO 10 MOXASedatelec2010-12-03ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262493107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262493107037602624931073760262493107

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableAn electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure1 KiloPascal2 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33472663322contact@sedatelec.com

Regulatory Flags#

DUNS number
266031462
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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03760262493404ASPASPMA3201132012023-01-12
03760262493411ASPASPMG3201132022023-01-12
03760262493428ASPASPMT3201132032023-01-12
03760262493435ASPASPMA1201132042023-01-12
03760262493442ASPASPMG1201132052023-01-12
03760262493459ASPASPMT1201132062023-01-12
03760262493466ASPASPMTEST1132072023-01-12
03760262493473ASPASPA641132082023-01-12
03760262493480ASPASPG641132092023-01-12
03760262493497ASPASPT641132102023-01-12
03760262490427ASPASPA81106362016-09-22
03760262490465ASPASPG81106372016-09-22
03760262490564ASPASPT81106382016-09-22

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