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510(k) Data Aggregation
K Number
K161468Device Name
Transformair Indoor Air Purifier
Manufacturer
Transformair, LLC
Date Cleared
2017-02-08
(257 days)
Product Code
FRA
Regulation Number
880.6500Why did this record match?
Applicant Name (Manufacturer) :
Transformair, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.
Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:
| Organism | Name | Average Maximum log reduction /exposure time (hours) | | |
|---------------------|-------------------|------------------------------------------------------|-------------------|-------------------|
| | | Test temperature | | |
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus | 4.88 / 24 hours | 4.02 / 0.33 hours | 4.20 / 0.33 hours |
| Bacteria | Escherichia coli | 4.31 / 24 hours | 4.79 / 24 hours | 4.40 / 0.33 hours |
| Virus | MS2 bacteriophage | 4.13 / 24 hours | 4.25 / 24 hours | 5.51 / 24 hours |
| Virus | Phi-X174 | 4.37 / 24 hours | 4.37 / 24 hours | 4.37 / 24 hours |
| Mold endospore | Aspergillus Niger | 3.91 / 72 hours | 3.99 / 72 hours | 4.22 / 72 hours |
| Bacterial endospore | Bacillus globigii | 4.11 / 72 hours | 4.41 / 72 hours | 4.41 / 72 hours |
Device Description
Transformair® is a patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-filter, black light lamps, and a catalytic filter coated with a photocatalyst. The Transformair device has a metal housing with electronic controls and outer dimensions of 28.5 inches by 21 inches by 12.25 inches that is installed in the duct of a buildings HVAC system. The Transformair device has a pre-filter and a chamber equipped with 6 low energy ultraviolet lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
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