FDA Product Code
FDA Product Code HCC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5050
510(k) Clearances — 172 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K884135 | DM100 (DISTAL MONITOR - 100) | Bio.Logic, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K883597 | MYODAC | Thought Technology , Ltd. | 1988-11-16 | Traditional | PDF ↗ |
| K881416 | MYOTRAC | Thought Technology , Ltd. | 1988-09-26 | Traditional | PDF ↗ |
| K882266 | DIGITAL EMG MONITOR MYOTRON 120 | Ats Co. | 1988-08-15 | Traditional | PDF ↗ |
| K882062 | MODEL BIOSTAR | Targus Concepts | 1988-06-17 | Traditional | PDF ↗ |
| K880913 | M424 EMG MONITOR | Bio-Logic Devices | 1988-05-11 | Traditional | PDF ↗ |
| K880916 | M444 EMG MONITOR | Bio-Logic Devices | 1988-05-11 | Traditional | PDF ↗ |
| K880914 | T824 TEMPERATURE MONITOR | Bio-Logic Devices | 1988-05-11 | Traditional | PDF ↗ |
| K873834 | INET MODEL BIOVISION | Inet Corp. | 1988-03-24 | Traditional | PDF ↗ |
| K875308 | PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 | Self Regulation Systems, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K873418 | BODYLOG STRESS REDUCTION PACKAGE | Bodylog, Inc. | 1987-12-17 | Traditional | PDF ↗ |
| K872495 | BIOCOMP 2001 BIOFEEDBACK DEVICE | Biofeedback Research Institute, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K870568 | BIO-PROMPT(TM) | Physical Health Devices, Inc. | 1987-08-04 | Traditional | PDF ↗ |
| K870793 | SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE | Self Regulation Systems, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K861950 | THE FM-212A BIOFEEDBACK UNIT | Hosa Technology, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K860271 | BIOFEEDBACK MICROLAB | Hrm Software/Div. of Human Relations Media | 1986-06-18 | Traditional | PDF ↗ |
| K854277 | NEUROPATH 4000 | Therapeutic Technologies, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K852963 | MYO-ACTUATOR | Verimed Holdings, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K854208 | THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS | Bodylog, Inc. | 1986-01-14 | Traditional | PDF ↗ |
| K853806 | MA-400 EMB FEEDBACK DEVICE | Spectral Data Systems | 1985-12-10 | Traditional | PDF ↗ |
| K850849 | MYOMETER EMG BIOFEEDBACK DEVICE | Physio Technology, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K850759 | COMPUTER INTERFACE - BIOFEEDBACK | M.O.E Electronics Research & Prod. | 1985-05-23 | Traditional | PDF ↗ |
| K850642 | TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA | Thought Technology , Ltd. | 1985-05-17 | Traditional | PDF ↗ |
| K850643 | HR/BVP 100T HEART RATE MONITOR | Thought Technology , Ltd. | 1985-05-17 | Traditional | PDF ↗ |
| K843738 | CAB2 COMPUTER ASSISTED BIOFEEDBACK | Discrete Data Systems, Inc. | 1984-12-04 | Traditional | PDF ↗ |
| K843413 | STRESS CONTROL BIOFEEDBACK CARD | Pilgrim Plastic Products Co. | 1984-11-27 | Traditional | PDF ↗ |
| K842022 | EEG BIOFEEDBACK DEVICE | Electronics Research & Production | 1984-07-20 | Traditional | PDF ↗ |
| K842021 | EEG BIOFEEDBACK DEVICE ACCESSORY | Electronics Research & Production | 1984-07-20 | Traditional | PDF ↗ |
| K842023 | TEMP. & GSR BIOFEEDBACK DEVICE | Electronics Research & Production | 1984-07-20 | Traditional | PDF ↗ |
| K842288 | EEG 130 | Calnor of EL Paseo, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K842353 | TEMPERATURE 132 | Calnor of EL Paseo, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 | Calnor of EL Paseo, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K842354 | EMG MODEL 133 | Calnor of EL Paseo, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K841128 | RELAX STRESS REDUCTION SYS | Synapse Software Corp. | 1984-07-16 | Traditional | PDF ↗ |
| K840223 | ORION BIOFEEDBACK DATA ACQUISITION | Self Regulation Systems, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K834110 | ANTENSE ANTI-TENSION DEVICE | Bio Sig Instruments, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K834111 | ANTACHE ANTI-HEADACHE DEVICE | Bio Sig Instruments, Inc. | 1984-02-03 | Traditional | PDF ↗ |
| K834519 | CALMTONE | Thought Technology , Ltd. | 1984-01-30 | Traditional | PDF ↗ |
| K832714 | VERIMED MYOEXORCISER | Verimed Holdings, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K832333 | FEEDBACK EMG SYSTEM PE-020 | Bio-Feedback Systems, Inc. | 1983-09-01 | Traditional | PDF ↗ |
| K832146 | TA-400 TEMP. FEEDBACK DEVICE | Spectral Data Systems | 1983-08-16 | Traditional | PDF ↗ |
| K832122 | ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED | Fluidotherapy Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K823511 | EMG BIOFEEDBACK DEVICE | Nemectron Medical, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K830529 | BIOFEEDBACK-TRAINING INSTRUMENT | Relaxomat, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823381 | PROFESSIONAL MARK I BIOFEEDBACK SYS | Srs Co. | 1983-01-05 | Traditional | PDF ↗ |
| K823146 | CALMSET 3 TM | Thought Technology , Ltd. | 1982-12-03 | Traditional | PDF ↗ |
| K822814 | EMG 100T | Thought Technology , Ltd. | 1982-10-08 | Traditional | PDF ↗ |
| K812619 | ISOLATED VOLTAGE/FREQUENCY CONVERTER | Bio-Feedback Systems, Inc. | 1981-10-08 | Traditional | PDF ↗ |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | Life-Tech Instruments, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K810882 | ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A | Atlas Researches , Ltd. | 1981-05-27 | Traditional | PDF ↗ |
| K810880 | AR-1 PHYSIOLOGICAL PRODESSOR | Atlas Researches , Ltd. | 1981-05-27 | Traditional | PDF ↗ |
| K810881 | EMG 3510/EMG 3510D MYOFEEDBACK MONITORS | Atlas Researches , Ltd. | 1981-05-27 | Traditional | PDF ↗ |
| K810332 | SC/TEMP 300 | Thought Technology , Ltd. | 1981-05-18 | Traditional | PDF ↗ |
| K803099 | BIOFEEDBACK BIO 80 | Bimed, Inc. | 1981-03-02 | Traditional | PDF ↗ |
| K802390 | EMG-UT 30 | American Scientific Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K802391 | EMG-UT 40 | American Scientific Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K801049 | V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU | Nebulae Productions | 1980-06-26 | Traditional | PDF ↗ |
| K800319 | ALPHA DETECTOR | M.O.E Electronics Research & Prod. | 1980-03-03 | Traditional | PDF ↗ |
| K792115 | BIOFEEDBACK DEVICES & ACCESSORIES | M.O.E Electronics Research & Prod. | 1980-03-03 | Traditional | PDF ↗ |
| K792659 | FEEDBACK EDR SYSTEM MODEL ME-1 | Bio-Feedback Systems, Inc. | 1980-01-09 | Traditional | PDF ↗ |
| K791207 | APOLLO HEART RATE INDICATOR | Key Tronic Corp. | 1979-08-28 | Traditional | PDF ↗ |
| K790746 | THE BIONIC EXERCISER | Scudder Molner Instruments | 1979-05-14 | Traditional | PDF ↗ |
| K781634 | VISUALAX | Farrall Instruments, Inc. | 1978-10-03 | Traditional | PDF ↗ |
| K780436 | RELAX-A-TONE | Bio Response | 1978-05-12 | Traditional | PDF ↗ |
| K771577 | CLINICAL EMG MODEL 133 | Calnor of EL Paseo, Inc. | 1977-08-26 | Traditional | PDF ↗ |
| K771023 | ANALOG QUANTIFIER MODEL AQ-100 | Bio-Feedback Systems, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770787 | RELAXATION COURSE MODEL 1000 | Cybernetic Medical, Inc. | 1977-06-17 | Traditional | PDF ↗ |
| K770790 | FEEDBACK EDR SYSTEM MODEL EDR-100 | Bio-Feedback Systems, Inc. | 1977-05-10 | Traditional | PDF ↗ |
| K770663 | FEEDBACK EMG SYSTEM, MODEL PE-L00 | Bio-Feedback Systems, Inc. | 1977-04-26 | Traditional | PDF ↗ |
| K761350 | MYOTRON | Somatronics, Inc. | 1977-03-15 | Traditional | PDF ↗ |
| K770270 | TEMPERATURE FEEDBACK SYS, MODEL DT100 | Bio-Feedback Systems, Inc. | 1977-02-24 | Traditional | PDF ↗ |
| K760084 | MONITOR, GSR (NB-401) | Narco Bio-Systems | 1976-07-26 | Traditional | PDF ↗ |
Product code HCC · Class II · Neurology. Data: openFDA.