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510(k) Data Aggregation
K Number
K060975Device Name
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
Manufacturer
THERATECH, INC.
Date Cleared
2006-05-10
(30 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
THERATECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The WL-2206A1 and WL-2206A2 are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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K Number
K050847Device Name
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
Manufacturer
THERATECH, INC.
Date Cleared
2005-06-17
(74 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
THERATECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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K Number
K024100Device Name
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
Manufacturer
THERATECH, INC.
Date Cleared
2003-02-25
(75 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
THERATECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The WL-2206 is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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K Number
K021436Device Name
TTECH MODEL 200E + TENS DEVICE
Manufacturer
THERATECH, INC.
Date Cleared
2002-07-30
(85 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
THERATECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.
Device Description
The Ttech 200E + TENS Device is a battery-operated device that includes controllable output channels. This TENS device creates electrical impulses whose intensity, duration, number per second and modulation can be altered with the controls and switches. There are two separate amplitude controls (channels). Every channel can be connected with the lead wire, on which two pieces of electrodes are to be connected to the end of the wire to provide stimulation for the intended part of the body.
There are three operation modes:
- . Convention Mode (c)
- Burst Mode (b)
- Modulated Mode (c) .
The operator may choose any one of them, as applicable.
The device includes the following:
- 1 TENS Unit .
- . 2 Leads
- 1 9v Battery ●
- 1 Operation Manual .
- 1 Carrying Case .
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K Number
K013768Device Name
POWERED MUSCLE STIMULATOR
Manufacturer
THERATECH, INC.
Date Cleared
2002-07-03
(232 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
THERATECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As an NMES device, the Ttech NMES is indicated for the following conditions:
- Relaxation of muscle spasms .
- . Prevention or retardation of disuse atrophy
- Increasing local blood circulation .
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis; and
- t Maintaining or increasing range of motion
Device Description
The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.
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