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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
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Miscellaneous
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
MOC
Cushion, Flotation, Therapeutic
2
Product Code
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
2
Product Code
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
2
Product Code
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
2
Product Code
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
2
Product Code
BXB
Exerciser, Powered
1
Product Code
EGJ
Device, Iontophoresis, Other Uses
2
Product Code
K
24
2041
STOPWET iontophoresis apparatus (SW01)
2
Cleared 510(K)
K
24
1267
Hidroxa SE30
2
Cleared 510(K)
K
23
2020
Iontophoresis Electrodes
2
Cleared 510(K)
K
19
2749
Dermadry
2
Cleared 510(K)
K
19
1436
Saalio
2
Cleared 510(K)
K
17
0835
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
2
Cleared 510(K)
K
17
0291
IontoDC
2
Cleared 510(K)
K
15
0453
TULA Iontophoresis System with Earset
2
Cleared 510(K)
K
13
3033
HIDREX PSP1000
2
Cleared 510(K)
K
13
2832
ACTIVAPATCH ET IONTOPHORESIS PATCH
2
Cleared 510(K)
K
11
0636
TULA IONTOPHORESIS SYSTEM
2
Cleared 510(K)
K
08
3016
ACTHYDERM
2
Cleared 510(K)
K
09
1326
ACTIVAPATCH
2
Cleared 510(K)
K
08
0580
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
2
Cleared 510(K)
K
07
3276
IONTOPHORESIS SYSTEM
2
Cleared 510(K)
K
07
2946
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
07
0427
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
2
Cleared 510(K)
K
06
1849
MESODERM
2
Cleared 510(K)
K
06
2792
ERCHONIA IOTO_240
2
Cleared 510(K)
K
06
3465
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
2
Cleared 510(K)
K
06
1522
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
2
Cleared 510(K)
K
06
0814
DYNATRON ION IONTOPHORESIS ELECTRODE
2
Cleared 510(K)
K
06
0579
COMFORT/IO IONTOPHORESIS ELECTRODES
2
Cleared 510(K)
K
06
0236
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
2
Cleared 510(K)
K
05
2019
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
2
Cleared 510(K)
K
04
3047
DYNATRON IBOX IONTOPHORESIS DEVICE
2
Cleared 510(K)
K
04
2590
TRANSDERM IONTO SYSTEM, MK 2
2
Cleared 510(K)
K
04
1101
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
2
Cleared 510(K)
K
04
0495
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
2
Cleared 510(K)
K
03
2968
TRSANSDERM IONTO SYSTEM
2
Cleared 510(K)
K
03
1769
E-STRIP
2
Cleared 510(K)
K
03
1053
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
2
Cleared 510(K)
K
02
2950
MINIPHYSIONIZER 2.0 AND ELECTRODES
2
Cleared 510(K)
K
03
0395
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
2
Cleared 510(K)
K
02
0476
MEDION 6000
2
Cleared 510(K)
K
00
0574
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
2
Cleared 510(K)
K
99
3081
IO-DRIVE
2
Cleared 510(K)
K
99
2708
IONTOPATCH
2
Cleared 510(K)
K
99
1991
DUPEL IONTOPHORESIS SYSTEM
2
Cleared 510(K)
K
98
2668
PHORESOR II,MODEL PM900
2
Cleared 510(K)
K
98
3484
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
2
Cleared 510(K)
K
97
0491
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
2
Cleared 510(K)
K
96
4208
MD-1A GALVANIC UNIT
2
Cleared 510(K)
K
94
6337
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
2
Cleared 510(K)
K
93
5868
DYNAPHOR(TM) TWO
2
Cleared 510(K)
K
93
4335
PHORESOR II AUTO, MODEL PM800 MODIFICATION
2
Cleared 510(K)
K
93
2620
RH-806/GS MODEL TRANSQ(R)2
2
Cleared 510(K)
K
93
2621
RH-801/GS MODEL TRANSQ(R)1
2
Cleared 510(K)
K
91
5444
DUPEL IONTOPHORESIS DEVICE
2
Cleared 510(K)
K
91
3601
MICROPHOR
2
Cleared 510(K)
K
92
5800
RH-806, MODEL TRANSQ
2
Cleared 510(K)
K
92
5806
RH-801, MODEL TRANSQ
2
Cleared 510(K)
K
91
4264
TRANSQ 2
2
Cleared 510(K)
K
91
4621
IONTOPHORESIS DEVICE, MODIFICATION
2
Cleared 510(K)
K
91
2015
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
2
Cleared 510(K)
K
91
2014
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
2
Cleared 510(K)
K
90
3093
IONTOPHORESIS DEVICE
2
Cleared 510(K)
K
89
5365
MD-2 IONTOPHORESIS UNIT
2
Cleared 510(K)
K
89
6444
IONTOPHORESIS DEVICE - ELECTRODE RH 800
2
Cleared 510(K)
K
90
0363
NEOPHOR-MC
2
Cleared 510(K)
K
89
6703
TBD IONTOPHORESIS ELECTRODE
2
Cleared 510(K)
K
89
4549
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
2
Cleared 510(K)
K
88
4834
XOMED IONESTHETIZER(TM)
2
Cleared 510(K)
K
88
2554
MEDITRODE KIT
2
Cleared 510(K)
K
87
1869
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
2
Cleared 510(K)
K
87
2040
PHORESOR II (TM), MODEL PM700
2
Cleared 510(K)
K
86
3166
MODEL 6110 IONTOPHORETIC APPLICATOR
2
Cleared 510(K)
K
85
3635
SUBDERM TM
2
Cleared 510(K)
K
85
0508
LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES
2
Cleared 510(K)
K
84
2483
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
2
Cleared 510(K)
K
83
1320
DRIONIC
2
Cleared 510(K)
K
77
0717
IONTOPHORESIS SYSTEM MODULE, DM 500
2
Cleared 510(K)
K
77
1130
DESENSITRON
2
Cleared 510(K)
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
IKW
Utensil, Homemaking
1
Product Code
IKX
Aid, Transfer
1
Product Code
IKZ
Bed, Patient Rotation, Powered
2
Product Code
ILC
Utensil, Eating
1
Product Code
ILD
Adaptor, Dressing
1
Product Code
ILJ
Bath, Hydro-Massage
2
Product Code
ILK
Transport, Patient, Powered
2
Product Code
ILM
Bath, Sitz, Powered
2
Product Code
ILO
Pack, Hot Or Cold, Water Circulating
2
Product Code
ILS
Adaptor, Hygiene
1
Product Code
ILT
Adaptor, Recreational
1
Product Code
ILW
Adaptor, Grooming
1
Product Code
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
2
Product Code
ILY
Lamp, Infrared, Therapeutic Heating
2
Product Code
ILZ
Accessories, Traction
1
Product Code
IMA
Pack, Heat, Moist
1
Product Code
IMB
Cabinet, Moist Steam
2
Product Code
IMC
Bath, Paraffin
2
Product Code
IMD
Pack, Hot Or Cold, Disposable
1
Product Code
IME
Pack, Hot Or Cold, Reusable
1
Product Code
IMF
Unit, Chilling
1
Product Code
INX
Bed, Air Fluidized
2
Product Code
INY
Bed, Patient Rotation, Manual
1
Product Code
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
IOB
Lamp, Infrared, Non Heating
2
Product Code
IOD
Components, Exercise
1
Product Code
IOE
Bars, Parallel, Exercise
1
Product Code
IOG
Treadmill, Mechanical
1
Product Code
IOL
Treadmill, Powered
1
Product Code
ION
Exerciser, Non-Measuring
1
Product Code
IOQ
Bed, Flotation Therapy, Powered
2
Product Code
IPF
Stimulator, Muscle, Powered
2
Product Code
IRN
Device, Warning, Overload, External Limb, Powered
2
Product Code
IRO
Vibrator, Therapeutic
1
Product Code
IRP
Massager, Powered Inflatable Tube
2
Product Code
IRQ
Unit, Heating, Powered
1
Product Code
IRR
Bars, Parallel, Powered
1
Product Code
IRS
Head Halter, Traction
1
Product Code
IRT
Pad, Heating, Powered
2
Product Code
ISA
Massager, Therapeutic, Electric
1
Product Code
ISD
Exerciser, Measuring
2
Product Code
ITH
Equipment, Traction, Powered
2
Product Code
JFA
Exerciser, Finger, Powered
1
Product Code
JFB
Table, Physical Therapy, Multi Function
2
Product Code
KNL
Board, Scooter, Prone
1
Product Code
KNM
Device, Pressure Applying
1
Product Code
KTB
Device, Iontophoresis, Specific Uses
2
Product Code
KTC
Bath, Sitz, Nonpowered
1
Product Code
LBG
Device, Fluidized Therapy, Dry Heat
2
Product Code
LSB
Unit, Fluidotherapy
2
Product Code
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
LXJ
Interactive Rehabilitation Exercise Devices
2
Product Code
LYG
Massager, Therapeutic, Manual
1
Product Code
MPO
Infant Heel Warmer (Chemical Heat Pack)
1
Product Code
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
2
Product Code
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
2
Product Code
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
2
Product Code
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
2
Product Code
OMW
Adhesive Backed Thermal Skin Patches
1
Product Code
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
2
Product Code
PCD
Powered Stairway Chair Lift
2
Product Code
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
2
Product Code
PHW
Cold Pack And Vibrating Massager
1
Product Code
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
1
Product Code
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
2
Product Code
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
2
Product Code
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
2
Product Code
QTC
Adult Portable Bed Rails For Medical Purposes
1
Product Code
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
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subpart-f—physical-medicine-therapeutic-devices
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EGJ
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K991991
View Source
DUPEL IONTOPHORESIS SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991991
510(k) Type
Traditional
Applicant
EMPI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/10/1999
Days to Decision
88 days
Submission Type
Summary
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
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
MOC
Cushion, Flotation, Therapeutic
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
BXB
Exerciser, Powered
EGJ
Device, Iontophoresis, Other Uses
K
24
2041
STOPWET iontophoresis apparatus (SW01)
K
24
1267
Hidroxa SE30
K
23
2020
Iontophoresis Electrodes
K
19
2749
Dermadry
K
19
1436
Saalio
K
17
0835
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K
17
0291
IontoDC
K
15
0453
TULA Iontophoresis System with Earset
K
13
3033
HIDREX PSP1000
K
13
2832
ACTIVAPATCH ET IONTOPHORESIS PATCH
K
11
0636
TULA IONTOPHORESIS SYSTEM
K
08
3016
ACTHYDERM
K
09
1326
ACTIVAPATCH
K
08
0580
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
K
07
3276
IONTOPHORESIS SYSTEM
K
07
2946
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K
07
0427
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K
06
1849
MESODERM
K
06
2792
ERCHONIA IOTO_240
K
06
3465
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K
06
1522
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
K
06
0814
DYNATRON ION IONTOPHORESIS ELECTRODE
K
06
0579
COMFORT/IO IONTOPHORESIS ELECTRODES
K
06
0236
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K
05
2019
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
K
04
3047
DYNATRON IBOX IONTOPHORESIS DEVICE
K
04
2590
TRANSDERM IONTO SYSTEM, MK 2
K
04
1101
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
K
04
0495
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
K
03
2968
TRSANSDERM IONTO SYSTEM
K
03
1769
E-STRIP
K
03
1053
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
K
02
2950
MINIPHYSIONIZER 2.0 AND ELECTRODES
K
03
0395
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K
02
0476
MEDION 6000
K
00
0574
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
K
99
3081
IO-DRIVE
K
99
2708
IONTOPATCH
K
99
1991
DUPEL IONTOPHORESIS SYSTEM
K
98
2668
PHORESOR II,MODEL PM900
K
98
3484
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K
97
0491
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K
96
4208
MD-1A GALVANIC UNIT
K
94
6337
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
K
93
5868
DYNAPHOR(TM) TWO
K
93
4335
PHORESOR II AUTO, MODEL PM800 MODIFICATION
K
93
2620
RH-806/GS MODEL TRANSQ(R)2
K
93
2621
RH-801/GS MODEL TRANSQ(R)1
K
91
5444
DUPEL IONTOPHORESIS DEVICE
K
91
3601
MICROPHOR
K
92
5800
RH-806, MODEL TRANSQ
K
92
5806
RH-801, MODEL TRANSQ
K
91
4264
TRANSQ 2
K
91
4621
IONTOPHORESIS DEVICE, MODIFICATION
K
91
2015
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K
91
2014
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K
90
3093
IONTOPHORESIS DEVICE
K
89
5365
MD-2 IONTOPHORESIS UNIT
K
89
6444
IONTOPHORESIS DEVICE - ELECTRODE RH 800
K
90
0363
NEOPHOR-MC
K
89
6703
TBD IONTOPHORESIS ELECTRODE
K
89
4549
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K
88
4834
XOMED IONESTHETIZER(TM)
K
88
2554
MEDITRODE KIT
K
87
1869
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
K
87
2040
PHORESOR II (TM), MODEL PM700
K
86
3166
MODEL 6110 IONTOPHORETIC APPLICATOR
K
85
3635
SUBDERM TM
K
85
0508
LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES
K
84
2483
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
K
83
1320
DRIONIC
K
77
0717
IONTOPHORESIS SYSTEM MODULE, DM 500
K
77
1130
DESENSITRON
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
IKW
Utensil, Homemaking
IKX
Aid, Transfer
IKZ
Bed, Patient Rotation, Powered
ILC
Utensil, Eating
ILD
Adaptor, Dressing
ILJ
Bath, Hydro-Massage
ILK
Transport, Patient, Powered
ILM
Bath, Sitz, Powered
ILO
Pack, Hot Or Cold, Water Circulating
ILS
Adaptor, Hygiene
ILT
Adaptor, Recreational
ILW
Adaptor, Grooming
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
ILY
Lamp, Infrared, Therapeutic Heating
ILZ
Accessories, Traction
IMA
Pack, Heat, Moist
IMB
Cabinet, Moist Steam
IMC
Bath, Paraffin
IMD
Pack, Hot Or Cold, Disposable
IME
Pack, Hot Or Cold, Reusable
IMF
Unit, Chilling
INX
Bed, Air Fluidized
INY
Bed, Patient Rotation, Manual
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
IOB
Lamp, Infrared, Non Heating
IOD
Components, Exercise
IOE
Bars, Parallel, Exercise
IOG
Treadmill, Mechanical
IOL
Treadmill, Powered
ION
Exerciser, Non-Measuring
IOQ
Bed, Flotation Therapy, Powered
IPF
Stimulator, Muscle, Powered
IRN
Device, Warning, Overload, External Limb, Powered
IRO
Vibrator, Therapeutic
IRP
Massager, Powered Inflatable Tube
IRQ
Unit, Heating, Powered
IRR
Bars, Parallel, Powered
IRS
Head Halter, Traction
IRT
Pad, Heating, Powered
ISA
Massager, Therapeutic, Electric
ISD
Exerciser, Measuring
ITH
Equipment, Traction, Powered
JFA
Exerciser, Finger, Powered
JFB
Table, Physical Therapy, Multi Function
KNL
Board, Scooter, Prone
KNM
Device, Pressure Applying
KTB
Device, Iontophoresis, Specific Uses
KTC
Bath, Sitz, Nonpowered
LBG
Device, Fluidized Therapy, Dry Heat
LSB
Unit, Fluidotherapy
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
LXJ
Interactive Rehabilitation Exercise Devices
LYG
Massager, Therapeutic, Manual
MPO
Infant Heel Warmer (Chemical Heat Pack)
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
OMW
Adhesive Backed Thermal Skin Patches
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
PCD
Powered Stairway Chair Lift
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
PHW
Cold Pack And Vibrating Massager
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
QTC
Adult Portable Bed Rails For Medical Purposes
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
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subpart-f—physical-medicine-therapeutic-devices
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EGJ
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K991991
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DUPEL IONTOPHORESIS SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991991
510(k) Type
Traditional
Applicant
EMPI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/10/1999
Days to Decision
88 days
Submission Type
Summary