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Found 14 results
510(k) Data Aggregation
K Number
K053007Device Name
SKYLARK URO PROBE
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2005-12-05
(40 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.
Device Description
Not Found
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K Number
K050174Device Name
BIO-STIM KIT
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2005-09-07
(225 days)
Product Code
GZJ, NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.
Device Description
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K Number
K043306Device Name
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2005-06-06
(187 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.
Device Description
Skylark Infrared Lamp, Models SD-956IR and SD-100IR
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K Number
K034005Device Name
SDS-4I
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2004-11-18
(330 days)
Product Code
IPF, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication Use For EMS (Code 10, 20-22,30-33_) Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indication Use For IF (Code 11-18, 20-22,30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain. Powered muscle stimulators should only be used under medical supervision
Device Description
The SDS-41 like a number of legally marketed predicate devices incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. The SDS-41 is housed in a plastic enclosure. The front of the enclosure house character LCD display. The accessories provided with the SDS-41 include the output cable, the electrode pads, and the AC Charging Adapter. The SDS-4I muscle stimulation modality operates at a specified 23 volts max (into a 500 ohm load) and 46mA max (into a 500 ohm load) with a pulse width of 520us Max and a cycle frequency of 75 Hz (±5%). The pulse is Symmetrical bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting. The SDS-4I interferential modality operates at a specified 80 mA max (into a 500 ohm load). The carrier and interferential signals are sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference Signal frequency can be fixed (continuous) or carried based on three selections (variable).
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K Number
K002832Device Name
CONDUCTIVE GEL FOR ULTRASOUND
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2001-08-06
(329 days)
Product Code
GYB
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992652Device Name
SD-730 IF-SDS, PERFECT PULSE IF-SDS
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2000-02-03
(181 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **& SYSTEMS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1.Symptomatic relief of chronic, intractable pain
2.Management of pain associated with post-traumatic or post-operative conditions
Device Description
Not Found
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K Number
K990233Device Name
ST-302 INFRAREX
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1999-10-27
(275 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INFRAREX temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
Device Description
Not Found
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K Number
K984506Device Name
SD-100 SKYEAR THERMOMETER
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1999-07-29
(223 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SD-100 SKYEAR THERMOMETER is designed for file 3D 100 -
Device Description
Not Found
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K Number
K981449Device Name
SD-956 ULTRASOUND THERAPY
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-12-11
(233 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SD-956 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Device Description
SD-956 Ultrasound Therapy
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K Number
K983964Device Name
BATCH #6060 CONDUCTIVE GEL
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-12-09
(33 days)
Product Code
GYB, IKC
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
**SKYLARK DEVICE **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.
Device Description
BATCH #6060 CONDUCTIVE GEL
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