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 |
|---|---|---|---|
| May 27, 1981 | K810881 | EMG 3510/EMG 3510D MYOFEEDBACK MONITORS Atlas Researches , Ltd. | HCC |
| May 27, 1981 | K810880 | AR-1 PHYSIOLOGICAL PRODESSOR Atlas Researches , Ltd. | HCC |
| May 18, 1981 | K810332 | SC/TEMP 300 Thought Technology , Ltd. | HCC |
| Mar 2, 1981 | K803099 | BIOFEEDBACK BIO 80 Bimed, Inc. | HCC |
| Jan 9, 1981 | K802391 | EMG-UT 40 American Scientific Corp. | HCC |
| Jan 9, 1981 | K802390 | EMG-UT 30 American Scientific Corp. | HCC |
| Jun 26, 1980 | K801049 | V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU Nebulae Productions | HCC |
| Mar 3, 1980 | K800319 | ALPHA DETECTOR M.O.E Electronics Research & Prod. | HCC |
| Mar 3, 1980 | K792115 | BIOFEEDBACK DEVICES & ACCESSORIES M.O.E Electronics Research & Prod. | HCC |
| Jan 9, 1980 | K792659 | FEEDBACK EDR SYSTEM MODEL ME-1 Bio-Feedback Systems, Inc. | HCC |
| Aug 28, 1979 | K791207 | APOLLO HEART RATE INDICATOR Key Tronic Corp. | HCC |
| May 14, 1979 | K790746 | THE BIONIC EXERCISER Scudder Molner Instruments | HCC |
| Oct 3, 1978 | K781634 | VISUALAX Farrall Instruments, Inc. | HCC |
| May 12, 1978 | K780436 | RELAX-A-TONE Bio Response | HCC |
| Aug 26, 1977 | K771577 | CLINICAL EMG MODEL 133 Calnor of EL Paseo, Inc. | HCC |
| Jun 24, 1977 | K771023 | ANALOG QUANTIFIER MODEL AQ-100 Bio-Feedback Systems, Inc. | HCC |
| Jun 17, 1977 | K770787 | RELAXATION COURSE MODEL 1000 Cybernetic Medical, Inc. | HCC |
| May 10, 1977 | K770790 | FEEDBACK EDR SYSTEM MODEL EDR-100 Bio-Feedback Systems, Inc. | HCC |
| Apr 26, 1977 | K770663 | FEEDBACK EMG SYSTEM, MODEL PE-L00 Bio-Feedback Systems, Inc. | HCC |
| Mar 15, 1977 | K761350 | MYOTRON Somatronics, Inc. | HCC |
| Feb 24, 1977 | K770270 | TEMPERATURE FEEDBACK SYS, MODEL DT100 Bio-Feedback Systems, Inc. | HCC |
| Jul 26, 1976 | K760084 | MONITOR, GSR (NB-401) Narco Bio-Systems | HCC |
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