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 |
|---|---|---|---|
| Feb 27, 1996 | K953257 | ORALSENSOR Cycura Corp. | HCC |
| Nov 14, 1995 | K954127 | BIOFEEDBACK DEVICE Verimed Holdings, Inc. | HCC |
| Sep 20, 1995 | K951213 | RELAXPLUS Ultramind International , Ltd., IL | HCC |
| Sep 18, 1995 | K944615 | A620 EEG Stoelting Co. | HCC |
| Sep 15, 1995 | K945286 | THE BAGNOLI-2 EMG SYSTEM Delsys, Inc. | HCC |
| Sep 1, 1995 | K942769 | BIOINTEGRATOR, BIOINTEGRATOR PLUS Bio Research Institute | HCC |
| Aug 4, 1995 | K945826 | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS Medical Device Inspection Co., Inc. | HCC |
| Jun 23, 1995 | K951350 | MUSCLESENSE ELECTROMYOGRAPHY DEVICE Smith and Nephew Donjoy, Inc. | HCC |
| Jun 21, 1995 | K941959 | VERSATELL; VERSATELL-S Progressive Concepts, Inc. | HCC |
| Jun 14, 1995 | K951969 | MYOEXORCISER II FUAL Verimed Holdings, Inc. | HCC |
| May 19, 1995 | K930578 | AT33 EMG Autoject Systems, Inc. | HCC |
| May 18, 1995 | K930577 | AT64 SCR Autoject Systems, Inc. | HCC |
| May 18, 1995 | K930576 | AT42 Autoject Systems, Inc. | HCC |
| Feb 24, 1995 | K940050 | FOCUS EMG Fasstech | HCC |
| Feb 8, 1995 | K920038 | NEUROSEARCH-4 Lexicor | HCC |
| Jan 31, 1995 | K925750 | RELAXOMAT Relaxomat, Inc. | HCC |
| Jan 18, 1995 | K935853 | EMG TRAINER Unitech | HCC |
| Sep 2, 1994 | K922270 | PHYSIOTECH 4000 OR NORODYN 8000 Myo-Tronics, Inc. | HCC |
| Aug 5, 1994 | K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE Intercare Diagnostics, Inc. | HCC |
| Oct 21, 1993 | K914925 | MEDAC SYSTEM/3 Davicon, Inc. | HCC |
| Sep 22, 1993 | K922838 | NORODYN 2000 ELECTROMYOGRAPH Noromed, Inc. | HCC |
| Feb 2, 1993 | K925197 | PSI 220 DUAL EMG Fasstech | HCC |
| Nov 16, 1992 | K914920 | BIOFEEDBACK SYSTEM/3 Davicon, Inc. | HCC |
| Sep 9, 1992 | K915859 | MYOTRAC/S, MYODAC/S Thought Technology , Ltd., CA | HCC |
| Sep 9, 1992 | K915858 | MYOTRAC2 Thought Technology , Ltd., CA | HCC |
| Mar 26, 1992 | K913898 | MYOTRAC+/S, MYODAC+/S Thought Technology , Ltd., CA | HCC |
| Mar 20, 1992 | K911911 | MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM Medical Design & Manufacturing Corp. | HCC |
| Sep 6, 1991 | K912595 | AXIOM ELECTROMYOGRAPH The Computerist, Inc. | HCC |
| Apr 18, 1991 | K897132 | PATHWAY II ELECTROMYOGRAPH The Prometheus Group | HCC |
| Apr 12, 1991 | K905372 | MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 Bio-Feedback Systems, Inc. | HCC |
| Apr 10, 1991 | K905373 | MINIATURE TEMPERATURE TRAINER MODEL DT-002 Bio-Feedback Systems, Inc. | HCC |
| Feb 12, 1991 | K903497 | FLEXCOMP DSP & PROCOMP Thought Technology , Ltd., CA | HCC |
| Jan 25, 1991 | K902450 | BODYLOG ENHANCED STRESS REDUCTION PACKAGE Bodylog, Inc. | HCC |
| Oct 9, 1990 | K896409 | M(3):MICRO MUSCLE MONITOR Thought Technology , Ltd., CA | HCC |
| Oct 4, 1990 | K900639 | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER Dynatronics Laser Corp. | HCC |
| Apr 19, 1990 | K895635 | MYOSYSTEM 1000 ELECTROMYOGRAPH Noraxon USA, Inc. | HCC |
| Apr 13, 1990 | K895633 | MYOTRACE 10 BIOFEEDBACK DEVICE Noraxon USA, Inc. | HCC |
| Jan 16, 1990 | K894510 | BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH Capscan Corp. | HCC |
| Jan 3, 1990 | K890500 | ELT OR ERGONOMIC LIFT TRAINER Physical Health Devices, Inc. | HCC |
| Dec 13, 1989 | K892649 | VERIMED MYOEXORCISER III (MYO III) Verimed Holdings, Inc. | HCC |
| Oct 13, 1989 | K894840 | MYODAC2 BIOFEEDBACK DEVICE Thought Technology , Ltd., CA | HCC |
| Oct 13, 1989 | K892114 | ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM Eclosion, Inc. | HCC |
| Aug 21, 1989 | K891693 | AUTOMATED THERAPY SYSTEM Harding & Harris, Inc. | HCC |
| Apr 24, 1989 | K881164 | LEUNOMED RFB 5000 Hemodynamics, Inc. | HCC |
| Mar 23, 1989 | K884849 | BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR Moe | HCC |
| Feb 3, 1989 | K884851 | BIOFEEDBACK DEVICE TG3, TG4 Moe | HCC |
| Feb 2, 1989 | K884853 | BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1 Moe | HCC |
| Feb 2, 1989 | K884852 | BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. Moe | HCC |
| Feb 2, 1989 | K884850 | BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30 Moe | HCC |
| Feb 2, 1989 | K884848 | BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV Moe | HCC |
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