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Found 3 results
510(k) Data Aggregation
K Number
K061721Device Name
PEDI-SPIDER STRAP
Manufacturer
EMERGENCY PRODUCTS AND RESEARCH
Date Cleared
2006-08-17
(59 days)
Product Code
NZD
Regulation Number
880.6900Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height.
Device Description
The Pedi-Spider utilizes 1 ½" nylon or polypropylene material in a cargo net fashion with Velcro on the ends for securing the strap to the backboard.
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K Number
K051278Device Name
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
Manufacturer
RG ENT., INC.
Date Cleared
2006-06-29
(408 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility
Device Description
The Geratherm SOS-Vacutherm System is a combination product made of two primary components:
1. An electrically warmed panel. - Class II
2. A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).
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K Number
K030283Device Name
BABY POD
Manufacturer
PRISM ENTERPRISES, INC.
Date Cleared
2003-04-22
(85 days)
Product Code
FPP
Regulation Number
880.6900Why did this record match?
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Matched: '880.6900'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.
Device Description
Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.
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