Device, Biofeedback
Regulation 882.5050
0510(k)s in 12 months (172 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in HCC
| Company | 510(k)s | Recalls |
|---|---|---|
| Thought Technology , Ltd. | 14 | 0 |
| Bio-Feedback Systems, Inc. | 9 | 0 |
| Moe | 6 | 0 |
| Calnor of EL Paseo, Inc. | 5 | 0 |
| Fasstech | 5 | 0 |
| Verimed Holdings, Inc. | 5 | 0 |
| The Prometheus Group | 4 | 0 |
| Stoelting Co. | 4 | 0 |
| Atlas Researches , Ltd. | 3 | 0 |
| Autoject Systems, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 1989 | K884135 | DM100 (DISTAL MONITOR - 100) Bio.Logic, Inc. | HCC |
| Nov 16, 1988 | K883597 | MYODAC Thought Technology , Ltd., CA | HCC |
| Sep 26, 1988 | K881416 | MYOTRAC Thought Technology , Ltd., CA | HCC |
| Aug 15, 1988 | K882266 | DIGITAL EMG MONITOR MYOTRON 120 Ats Co. | HCC |
| Jun 17, 1988 | K882062 | MODEL BIOSTAR Targus Concepts | HCC |
| May 11, 1988 | K880916 | M444 EMG MONITOR Bio-Logic Devices | HCC |
| May 11, 1988 | K880914 | T824 TEMPERATURE MONITOR Bio-Logic Devices | HCC |
| May 11, 1988 | K880913 | M424 EMG MONITOR Bio-Logic Devices | HCC |
| Mar 24, 1988 | K873834 | INET MODEL BIOVISION Inet Corp. | HCC |
| Feb 26, 1988 | K875308 | PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421 Self Regulation Systems, Inc. | HCC |
| Dec 17, 1987 | K873418 | BODYLOG STRESS REDUCTION PACKAGE Bodylog, Inc. | HCC |
| Aug 4, 1987 | K872495 | BIOCOMP 2001 BIOFEEDBACK DEVICE Biofeedback Research Institute, Inc. | HCC |
| Aug 4, 1987 | K870568 | BIO-PROMPT(TM) Physical Health Devices, Inc. | HCC |
| May 1, 1987 | K870793 | SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE Self Regulation Systems, Inc. | HCC |
| Apr 22, 1987 | K861950 | THE FM-212A BIOFEEDBACK UNIT Hosa Technology, Inc. | HCC |
| Jun 18, 1986 | K860271 | BIOFEEDBACK MICROLAB Hrm Software/Div. of Human Relations Media | HCC |
| Jan 21, 1986 | K854277 | NEUROPATH 4000 Therapeutic Technologies, Inc. | HCC |
| Jan 21, 1986 | K852963 | MYO-ACTUATOR Verimed Holdings, Inc. | HCC |
| Jan 14, 1986 | K854208 | THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS Bodylog, Inc. | HCC |
| Dec 10, 1985 | K853806 | MA-400 EMB FEEDBACK DEVICE Spectral Data Systems | HCC |
| May 31, 1985 | K850849 | MYOMETER EMG BIOFEEDBACK DEVICE Physio Technology, Inc. | HCC |
| May 23, 1985 | K850759 | COMPUTER INTERFACE - BIOFEEDBACK M.O.E Electronics Research & Prod. | HCC |
| May 17, 1985 | K850643 | HR/BVP 100T HEART RATE MONITOR Thought Technology , Ltd., CA | HCC |
| May 17, 1985 | K850642 | TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA Thought Technology , Ltd., CA | HCC |
| Dec 4, 1984 | K843738 | CAB2 COMPUTER ASSISTED BIOFEEDBACK Discrete Data Systems, Inc. | HCC |
| Nov 27, 1984 | K843413 | STRESS CONTROL BIOFEEDBACK CARD Pilgrim Plastic Products Co. | HCC |
| Jul 20, 1984 | K842023 | TEMP. & GSR BIOFEEDBACK DEVICE Electronics Research & Production | HCC |
| Jul 20, 1984 | K842022 | EEG BIOFEEDBACK DEVICE Electronics Research & Production | HCC |
| Jul 20, 1984 | K842021 | EEG BIOFEEDBACK DEVICE ACCESSORY Electronics Research & Production | HCC |
| Jul 17, 1984 | K842354 | EMG MODEL 133 Calnor of EL Paseo, Inc. | HCC |
| Jul 17, 1984 | K842353 | TEMPERATURE 132 Calnor of EL Paseo, Inc. | HCC |
| Jul 17, 1984 | K842288 | EEG 130 Calnor of EL Paseo, Inc. | HCC |
| Jul 17, 1984 | K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 Calnor of EL Paseo, Inc. | HCC |
| Jul 16, 1984 | K841128 | RELAX STRESS REDUCTION SYS Synapse Software Corp. | HCC |
| Mar 9, 1984 | K840223 | ORION BIOFEEDBACK DATA ACQUISITION Self Regulation Systems, Inc. | HCC |
| Feb 4, 1984 | K834110 | ANTENSE ANTI-TENSION DEVICE Bio Sig Instruments, Inc. | HCC |
| Feb 3, 1984 | K834111 | ANTACHE ANTI-HEADACHE DEVICE Bio Sig Instruments, Inc. | HCC |
| Jan 30, 1984 | K834519 | CALMTONE Thought Technology , Ltd. | HCC |
| Oct 28, 1983 | K832714 | VERIMED MYOEXORCISER Verimed Holdings, Inc. | HCC |
| Sep 1, 1983 | K832333 | FEEDBACK EMG SYSTEM PE-020 Bio-Feedback Systems, Inc. | HCC |
| Aug 16, 1983 | K832146 | TA-400 TEMP. FEEDBACK DEVICE Spectral Data Systems | HCC |
| Aug 12, 1983 | K832122 | ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED Fluidotherapy Corp. | HCC |
| Mar 31, 1983 | K823511 | EMG BIOFEEDBACK DEVICE Nemectron Medical, Inc. | HCC |
| Mar 24, 1983 | K830529 | BIOFEEDBACK-TRAINING INSTRUMENT Relaxomat, Inc. | HCC |
| Jan 5, 1983 | K823381 | PROFESSIONAL MARK I BIOFEEDBACK SYS Srs Co. | HCC |
| Dec 3, 1982 | K823146 | CALMSET 3 TM Thought Technology , Ltd. | HCC |
| Oct 8, 1982 | K822814 | EMG 100T Thought Technology , Ltd. | HCC |
| Oct 8, 1981 | K812619 | ISOLATED VOLTAGE/FREQUENCY CONVERTER Bio-Feedback Systems, Inc. | HCC |
| Aug 25, 1981 | K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER Life-Tech Instruments, Inc. | HCC |
| May 27, 1981 | K810882 | ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A Atlas Researches , Ltd. | HCC |
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