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510(k) Data Aggregation
K Number
K970363Device Name
HYDROTEC LOW AIR LOSS THERAPY BED
Manufacturer
APEX METAL, INC.
Date Cleared
1997-11-17
(290 days)
Product Code
IOQ
Regulation Number
890.5170Why did this record match?
Applicant Name (Manufacturer) :
APEX METAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers ( bed sores).
Device Description
Not Found
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K Number
K970364Device Name
AIRTEC2 LOW AIR LOSS THERAPY BED
Manufacturer
APEX METAL, INC.
Date Cleared
1997-11-17
(290 days)
Product Code
IOQ
Regulation Number
890.5170Why did this record match?
Applicant Name (Manufacturer) :
APEX METAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.
Device Description
AirTec2™ Low Air Loss Therapy Bed
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K Number
K970362Device Name
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
Manufacturer
APEX METAL, INC.
Date Cleared
1997-05-16
(105 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
APEX METAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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