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Found 10 results
510(k) Data Aggregation
K Number
K070402Device Name
MODIFICATION TO POLAR CARE 500
Manufacturer
BREG, INC.
Date Cleared
2007-03-29
(45 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
- Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
- Temporary decrease in blood circulation, where applied, . reduces pain and swelling.
Device Description
Not Found
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K Number
K041714Device Name
E-PAIN CARE
Manufacturer
BREG, INC.
Date Cleared
2004-10-01
(100 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.
Device Description
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K Number
K020988Device Name
PAIN CARE 4200
Manufacturer
BREG, INC.
Date Cleared
2002-04-04
(8 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.
Device Description
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K Number
K013928Device Name
PAIN CARE 3200
Manufacturer
BREG, INC.
Date Cleared
2001-12-03
(5 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain.
The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
Device Description
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K Number
K003611Device Name
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
Manufacturer
BREG, INC.
Date Cleared
2000-12-13
(21 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002073Device Name
PAIN CARE 3000
Manufacturer
BREG, INC.
Date Cleared
2000-09-19
(71 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002321Device Name
PAIN CARE 2000L
Manufacturer
BREG, INC.
Date Cleared
2000-08-14
(14 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983454Device Name
PAIN CARE 2000
Manufacturer
BREG, INC.
Date Cleared
1998-12-16
(77 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
Device Description
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K Number
K963596Device Name
POLAR CARE 300
Manufacturer
BREG, INC.
Date Cleared
1996-12-04
(86 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961855Device Name
POLAR CARE (MODEL 500/50000)
Manufacturer
BREG, INC.
Date Cleared
1996-08-09
(87 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
BREG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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