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LDK
Device, Sensing, Optical Contour
U
Product Code
LWB
Stimulator, Functional Neuromuscular, Scoliosis
3
Product Code
LXM
Manipulator, Plunger-Like Joint
U
Product Code
K
23
4036
SONIK MONARK 100
U
Cleared 510(K)
K
19
2629
Spinalytics
U
Cleared 510(K)
K
17
2536
Atlas Percussion Adjusting Instrument
U
Cleared 510(K)
K
16
0278
VSTAAR AdjusteR
U
Cleared 510(K)
K
13
0666
KHAN KINETIC TREATMENT (KKT-M2)
U
Cleared 510(K)
K
11
2606
ACTIVATOR V-E
U
Cleared 510(K)
K
08
2218
MAX ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
08
0261
IMPULSE IQ ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
07
2519
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
06
0043
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
U
Cleared 510(K)
K
05
0428
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
U
Cleared 510(K)
K
02
3462
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003
U
Cleared 510(K)
K
02
1238
FRYE ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
01
0851
HARRISON HAND HELD ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
00
3185
FS ACTIVATOR III
U
Cleared 510(K)
K
00
1476
TORQUE INSTRUMENT, MODEL 8500
U
Cleared 510(K)
K
97
3914
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
U
Cleared 510(K)
K
97
4376
JTECH ADJUSTER REFLEX GUN
U
Cleared 510(K)
K
97
3506
ACTIVATOR II
U
Cleared 510(K)
K
96
2239
SMART ADJUSTER (SA201)
U
Cleared 510(K)
K
95
0646
INTEGRATOR
U
Cleared 510(K)
K
95
5540
HAND HELD ATLAS INSTRUMENT
U
Cleared 510(K)
K
95
1217
ATLAS ORTHOGONAL PERCUSSION INSTTUMENT
U
Cleared 510(K)
K
94
6258
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
U
Cleared 510(K)
K
94
4369
NEW-STIM SPINAL ADJUSTMENT INSTRUMENT
U
Cleared 510(K)
K
94
0085
FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01
U
Cleared 510(K)
K
93
0431
ARTHROSTIM MANIPULATOR
U
Cleared 510(K)
K
92
2692
KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR
U
Cleared 510(K)
K
92
2695
KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5
U
Cleared 510(K)
K
92
2694
KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4
U
Cleared 510(K)
K
92
2693
KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1
U
Cleared 510(K)
K
87
0910
PRECISION SPINAL ADJUSTER MODEL 115
U
Cleared 510(K)
LZW
Monitor, Spine Curvature
U
Product Code
MBQ
Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
3
Product Code
MLY
Vapocoolant Device
U
Product Code
QPY
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
3
Product Code
QWI
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
2
Product Code
SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Radiology
Review Panel
General and Plastic Surgery
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Toxicology
Review Panel
Medical Genetics
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Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
PM
/
PM-misc
/
LXM
/
K950646
View Source
INTEGRATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K950646
510(k) Type
Traditional
Applicant
MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1996
Days to Decision
442 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Miscellaneous
LDK
Device, Sensing, Optical Contour
LWB
Stimulator, Functional Neuromuscular, Scoliosis
LXM
Manipulator, Plunger-Like Joint
K
23
4036
SONIK MONARK 100
K
19
2629
Spinalytics
K
17
2536
Atlas Percussion Adjusting Instrument
K
16
0278
VSTAAR AdjusteR
K
13
0666
KHAN KINETIC TREATMENT (KKT-M2)
K
11
2606
ACTIVATOR V-E
K
08
2218
MAX ADJUSTING INSTRUMENT
K
08
0261
IMPULSE IQ ADJUSTING INSTRUMENT
K
07
2519
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
K
06
0043
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
K
05
0428
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
K
02
3462
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003
K
02
1238
FRYE ADJUSTING INSTRUMENT
K
01
0851
HARRISON HAND HELD ADJUSTING INSTRUMENT
K
00
3185
FS ACTIVATOR III
K
00
1476
TORQUE INSTRUMENT, MODEL 8500
K
97
3914
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
K
97
4376
JTECH ADJUSTER REFLEX GUN
K
97
3506
ACTIVATOR II
K
96
2239
SMART ADJUSTER (SA201)
K
95
0646
INTEGRATOR
K
95
5540
HAND HELD ATLAS INSTRUMENT
K
95
1217
ATLAS ORTHOGONAL PERCUSSION INSTTUMENT
K
94
6258
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
K
94
4369
NEW-STIM SPINAL ADJUSTMENT INSTRUMENT
K
94
0085
FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01
K
93
0431
ARTHROSTIM MANIPULATOR
K
92
2692
KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR
K
92
2695
KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5
K
92
2694
KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4
K
92
2693
KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1
K
87
0910
PRECISION SPINAL ADJUSTER MODEL 115
LZW
Monitor, Spine Curvature
MBQ
Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
MLY
Vapocoolant Device
QPY
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
QWI
Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Submissions with No Product Code
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
/
PM-misc
/
LXM
/
K950646
View Source
INTEGRATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K950646
510(k) Type
Traditional
Applicant
MOYCO UNION BROACH, DIV., MOYCO TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1996
Days to Decision
442 days
Submission Type
Statement