Search Results
Found 8 results
510(k) Data Aggregation
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., LTD.
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
Ask a Question
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., LTD.
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
Ask a Question
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., LTD.
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
Ask a Question
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., LTD.
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
Ask a Question
K Number
K964437Device Name
GB-1002 TENS WITH MASSAGE
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-08-14
(647 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SKYLARK DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DE VICES ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (I ONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACTIES AND PAINS.
Device Description
GB-1002 TENS WITH VIBRATOR
Ask a Question
K Number
K974585Device Name
IF-727 INTERFERENTIAL STIMULATOR
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1998-03-06
(88 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SKYLARK DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.
Device Description
Not Found
Ask a Question
K Number
K964434Device Name
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1997-10-09
(338 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SKYLARK DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. RELAXATION OF MUSCLE SPASM.
- 2. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
- 3. INCREASING LOCAL BLOOD CIRCULATION.
- 4. MUSCLE-RE-EDUCATION.
- 5. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
- 6. MAINTAINING OR INCREASING RANGE OF MOTION.
Device Description
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
Ask a Question
K Number
K963729Device Name
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1997-02-13
(150 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SKYLARK DEVICE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1