BioStimul Handpiece

GUDID 08034108512419

The BioStimul Handpiece is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscolar and joint pain and stiffness, minor arthrits pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. The spot diameter at 1 cm out of the handpiece is 5 mm. The BioStimul Handpiece is supplied together with a suitable optical fiber.

DEKA M.E.L.A. SRL

Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable
Primary Device ID08034108512419
NIH Device Record Keydd8c96f8-2308-45a0-949d-8f46e0857149
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioStimul Handpiece
Version Model NumberN378C1
Company DUNS629381096
Company NameDEKA M.E.L.A. SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108034108512419 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

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