Search Results
Found 4 results
510(k) Data Aggregation
K Number
K080102Device Name
TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
Manufacturer
ESCADA INTERNATIONAL, INC.
Date Cleared
2008-08-20
(219 days)
Product Code
ILY, GEX
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ESCADA INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All four devices are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
Not Found
Ask a Question
K Number
K071445Device Name
TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
Manufacturer
ESCADA INTERNATIONAL, INC.
Date Cleared
2007-10-29
(158 days)
Product Code
ILY, GEX, GZJ
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ESCADA INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TerraQuant MQ2000 v.5 with the TQ-1TENS is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Device Description
Not Found
Ask a Question
K Number
K061614Device Name
TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
Manufacturer
ESCADA INTERNATIONAL, INC.
Date Cleared
2006-10-06
(119 days)
Product Code
ILY, GEX
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ESCADA INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers are non-invasive infrared lamps intended to provide topical heating. The Terraquant MQ2000 v.5 and HandyRx Laser MQ2007 Lasers are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
The Escada Terraquant MQ2000 Laser Therapy Device has been modified resulting in the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers. The Terraquant MQ2000 was modified to increase the power level range for the laser from .4 to 1.4 mW to .4 to 7.5 mW and to provide the device in a hand held configuration. The proposed Terraquant MQ2000 v.5 (increased power but same configuration as Terraquant MQ2000) and the HandyRx MQ2007 (increased power level in a hand held configuration) are essentially identical in intended use and fundamental technology to the parent Terraquant MQ2000 Laser Therapy Device described in K043055. As with the original Terraquant MQ2000 system, the Terraquant MQ2000 v.5 and HandyRx MQ2007 System utilize heating lamps consisting of a laser diode, infrared diodes, and a visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The parent Terraquant MQ2000 system and the Terraquant MQ2000 v. 5 consist of a desktop control unit, and a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The proposed HandyRx MQ2007 consists of only the handheld emitter from which the laser and other radiances are released. Both the parent and proposed device laser and light therapies release radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
Ask a Question
K Number
K043055Device Name
TERRAQUANT MQ2000 LASER THERAPY DEVICE
Manufacturer
ESCADA INTERNATIONAL, INC.
Date Cleared
2005-07-25
(262 days)
Product Code
ILY, 79G
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ESCADA INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
Ask a Question
Page 1 of 1