FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
MNW
Analyzer, Body Composition
2
Product Code
K
23
1116
Multi-parameter detector
2
Cleared 510(K)
K
14
0045
BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
14
1483
BIOSPACE BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
13
3872
ARIA WIFI SMART SCALE
2
Cleared 510(K)
K
14
0594
BODY FAT ANALYZER AND SCALE
2
Cleared 510(K)
K
13
0856
BIA / VITALITY ANALYZER
2
Cleared 510(K)
K
13
0777
INBODY
2
Cleared 510(K)
K
13
0952
PRECISION ONE LIFECARE; DETECTO; DETECTO
2
Cleared 510(K)
K
13
1394
TRANSTEK GLASS BODY FAT ANALYZER
2
Cleared 510(K)
K
13
0311
TRANSTEK BODY FAT ANALYZER
2
Cleared 510(K)
K
12
2388
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
2
Cleared 510(K)
K
12
3228
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
2
Cleared 510(K)
K
12
3781
TRANSTEK GLASS BODY FAT ANALYZER
2
Cleared 510(K)
K
12
2976
BODY FAT SCALE MODEL SF-371
2
Cleared 510(K)
K
12
1971
WITHINGS, SMART BODY SCALE
2
Cleared 510(K)
K
12
0896
WI-FI BODY SCALE
2
Cleared 510(K)
K
12
1527
WI-FI BODY SCALE
2
Cleared 510(K)
K
11
2149
WEIGHT AND BODY FAT SCALE SHINE BS0105
2
Cleared 510(K)
K
11
2951
BODY ANALYSIS SCALE
2
Cleared 510(K)
K
11
2932
TRANSTEK
2
Cleared 510(K)
K
11
1404
HUIBAO BODY FAT SCALE
2
Cleared 510(K)
K
11
0689
INBODY
2
Cleared 510(K)
K
11
0928
BODY ANALYSIS SCALE, MODEL BG 17
2
Cleared 510(K)
K
10
2191
TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
2
Cleared 510(K)
K
10
0183
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
10
3026
ELECTRO SENSOR -BODY COMPOSITION
2
Cleared 510(K)
K
08
2254
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
2
Cleared 510(K)
K
08
2255
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
2
Cleared 510(K)
K
10
1807
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
2
Cleared 510(K)
K
09
2786
INBODY, MODELS: 270, R20, R20B
2
Cleared 510(K)
K
09
1369
ELECTROFLUIDGRAPH
2
Cleared 510(K)
K
09
2431
BODY COMPOSITION ANALYZER, MODEL: IOI 353
2
Cleared 510(K)
K
09
0479
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
2
Cleared 510(K)
K
08
3838
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
2
Cleared 510(K)
K
08
2253
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
2
Cleared 510(K)
K
08
1587
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
2
Cleared 510(K)
K
07
3334
OHMNISCAN NG
2
Cleared 510(K)
K
07
3227
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
2
Cleared 510(K)
K
07
2325
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
2
Cleared 510(K)
K
07
1884
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
2
Cleared 510(K)
K
07
0999
BC (BODY COMPOSITION SOFTWARE)
2
Cleared 510(K)
K
06
2603
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
2
Cleared 510(K)
K
06
2652
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
2
Cleared 510(K)
K
06
2043
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
2
Cleared 510(K)
K
06
0538
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
2
Cleared 510(K)
K
05
3556
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
2
Cleared 510(K)
K
06
0642
DUTECK BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
06
0552
BC100 BODY COMPOSITION ANALYSIS SYSTEM
2
Cleared 510(K)
K
05
2319
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
2
Cleared 510(K)
K
05
1675
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
05
2678
AQ-830 SLIM BODY, BODY FAT MONITOR
2
Cleared 510(K)
K
05
2646
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
2
Cleared 510(K)
K
05
2522
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
2
Cleared 510(K)
K
05
1589
SLIMMANAGER, MODEL SM-X, SM-E
2
Cleared 510(K)
K
05
0395
IMPEDIMED - BODY COMPOSITION ANALYSIS
2
Cleared 510(K)
K
04
3414
HL 188 & HL 189 BODY FAT METER
2
Cleared 510(K)
K
04
3060
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
2
Cleared 510(K)
K
04
2528
INBODY, MODEL 3.0
2
Cleared 510(K)
K
04
0778
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
2
Cleared 510(K)
K
04
0978
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
2
Cleared 510(K)
K
03
3157
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
2
Cleared 510(K)
K
03
1167
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
2
Cleared 510(K)
K
02
3429
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
2
Cleared 510(K)
K
03
1582
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
2
Cleared 510(K)
K
02
3817
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
2
Cleared 510(K)
K
02
0738
AVITA BF1 (VITALIO) BODY FAT ANALYZER
2
Cleared 510(K)
K
02
3478
INBODY AP1 BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
03
0349
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
2
Cleared 510(K)
K
03
0203
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
2
Cleared 510(K)
K
02
3942
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311
2
Cleared 510(K)
K
01
4009
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
2
Cleared 510(K)
K
01
1652
BODY FAT ANALYZER, MODEL HBF-306
2
Cleared 510(K)
K
01
0706
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
2
Cleared 510(K)
K
00
2835
BODYSTAT
2
Cleared 510(K)
K
99
4242
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
2
Cleared 510(K)
K
96
3271
FUTREX-6100/XL
2
Cleared 510(K)
K
98
0971
BODYSTAT DUALSCAN 2005
2
Cleared 510(K)
K
97
1554
BODYSTAT
2
Cleared 510(K)
K
96
3575
HBF-1000 OMRON BODY COMPOSITION ANALYZER
2
Cleared 510(K)
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
2
Product Code
OMV
Ultrasonic Body Composition Analyzer
2
Product Code
PUH
Analyzer, Body Composition, Exempt
2
Product Code
QJB
Adjunct Monitor, Protein Calorie Malnutrition
2
Product Code
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical 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
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
GU
/
subpart-c—cardiovascular-monitoring-devices
/
MNW
/
K043414
View Source
HL 188 & HL 189 BODY FAT METER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043414
510(k) Type
Traditional
Applicant
HEALTH & LIFE CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2005
Days to Decision
58 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
MNW
Analyzer, Body Composition
K
23
1116
Multi-parameter detector
K
14
0045
BODY COMPOSITION ANALYZER
K
14
1483
BIOSPACE BODY COMPOSITION ANALYZER
K
13
3872
ARIA WIFI SMART SCALE
K
14
0594
BODY FAT ANALYZER AND SCALE
K
13
0856
BIA / VITALITY ANALYZER
K
13
0777
INBODY
K
13
0952
PRECISION ONE LIFECARE; DETECTO; DETECTO
K
13
1394
TRANSTEK GLASS BODY FAT ANALYZER
K
13
0311
TRANSTEK BODY FAT ANALYZER
K
12
2388
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K
12
3228
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
K
12
3781
TRANSTEK GLASS BODY FAT ANALYZER
K
12
2976
BODY FAT SCALE MODEL SF-371
K
12
1971
WITHINGS, SMART BODY SCALE
K
12
0896
WI-FI BODY SCALE
K
12
1527
WI-FI BODY SCALE
K
11
2149
WEIGHT AND BODY FAT SCALE SHINE BS0105
K
11
2951
BODY ANALYSIS SCALE
K
11
2932
TRANSTEK
K
11
1404
HUIBAO BODY FAT SCALE
K
11
0689
INBODY
K
11
0928
BODY ANALYSIS SCALE, MODEL BG 17
K
10
2191
TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
K
10
0183
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
K
10
3026
ELECTRO SENSOR -BODY COMPOSITION
K
08
2254
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K
08
2255
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
K
10
1807
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
K
09
2786
INBODY, MODELS: 270, R20, R20B
K
09
1369
ELECTROFLUIDGRAPH
K
09
2431
BODY COMPOSITION ANALYZER, MODEL: IOI 353
K
09
0479
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
K
08
3838
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
K
08
2253
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
K
08
1587
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
K
07
3334
OHMNISCAN NG
K
07
3227
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
K
07
2325
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
K
07
1884
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
K
07
0999
BC (BODY COMPOSITION SOFTWARE)
K
06
2603
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
K
06
2652
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
K
06
2043
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K
06
0538
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
K
05
3556
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
K
06
0642
DUTECK BODY COMPOSITION ANALYZER
K
06
0552
BC100 BODY COMPOSITION ANALYSIS SYSTEM
K
05
2319
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
K
05
1675
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
K
05
2678
AQ-830 SLIM BODY, BODY FAT MONITOR
K
05
2646
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K
05
2522
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K
05
1589
SLIMMANAGER, MODEL SM-X, SM-E
K
05
0395
IMPEDIMED - BODY COMPOSITION ANALYSIS
K
04
3414
HL 188 & HL 189 BODY FAT METER
K
04
3060
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K
04
2528
INBODY, MODEL 3.0
K
04
0778
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
K
04
0978
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
K
03
3157
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
K
03
1167
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
K
02
3429
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K
03
1582
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K
02
3817
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K
02
0738
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K
02
3478
INBODY AP1 BODY COMPOSITION ANALYZER
K
03
0349
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
K
03
0203
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K
02
3942
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311
K
01
4009
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
K
01
1652
BODY FAT ANALYZER, MODEL HBF-306
K
01
0706
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
K
00
2835
BODYSTAT
K
99
4242
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K
96
3271
FUTREX-6100/XL
K
98
0971
BODYSTAT DUALSCAN 2005
K
97
1554
BODYSTAT
K
96
3575
HBF-1000 OMRON BODY COMPOSITION ANALYZER
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
OMV
Ultrasonic Body Composition Analyzer
PUH
Analyzer, Body Composition, Exempt
QJB
Adjunct Monitor, Protein Calorie Malnutrition
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-c—cardiovascular-monitoring-devices
/
MNW
/
K043414
View Source
HL 188 & HL 189 BODY FAT METER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043414
510(k) Type
Traditional
Applicant
HEALTH & LIFE CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2005
Days to Decision
58 days
Submission Type
Summary