Product code HCC— Neurology
A Breathing System (ABS)
- Classification name
- Device, Biofeedback
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Total cleared
- 172
- First cleared
- Most recent
Market context for product code HCC
FDA has cleared devices under product code HCC between 1976 and 2024, filed by 98 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2018
- 2017
- 2015
- 2013
- 2011
- 2010
- 2008
- 2007
- 2004
- 2002
- 2001
- 2000
- 1999
Top applicants under product code HCC
Recent clearances under product code HCC
1–100 of 172- K233580 — A Breathing System (ABS)
- K222101 — Prism
- K180173 — Freespira
- K163448 — GrindCare System
- K151050 — Pacifier Activated Lullaby (PAL®)
- K143507 — NFANT Feeding Solution
- K131586 — CANARY BREATHING SYSTEM
- K122879 — EEGER4 MODEL 4.3
- K111687 — EMG SYSTEM
- K092675 — GRINDCARE
- K073557 — EEG NEUROAMP, MODEL CS10137
- K071866 — NTRAINER SYSTEM
- K071661 — ALPHAONE BIOFEEDBACK SYSTEM
- K041244 — POLYGRAM NET BIOFEEDBACK APPLICATION
- K020399 — RESPERATE; MODEL RR-150
- K010388 — SONDREX P.A.L. SYSTEM
- K013399 — MODEL MES-9000/EMG SYSTEM
- K012384 — EAR MUFFINS
- K012011 — MODIFICATION TO A620 EEG
- K011964 — INSIGHT MILLENNIUM PLUS
- K011823 — BIOREHAB SYSTEM
- K011983 — INSIGHT GENESIS
- K003127 — REGAIN DESKTOP
- K003367 — ORION PLATINUM
- K000405 — INTERCURE LTD. RESPI-LOW
- K993654 — NEUROCOMP
- K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000
- K990778 — INSIGHT MILLENNIUM
- K990538 — BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
- K990356 — THE BAGNOLI-8 EMG SYSTEM
- K983550 — XYZ SYSTEM
- K981934 — THE BAGNOLI-4 EMG SYSTEM
- K981844 — SLEEP MANAGEMENT SYSTEM
- K980373 — ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
- K971400 — MUSCLE RESPONSE MONITOR
- K971708 — PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
- K973537 — PATHWAY ELECTROMYOGRAPH
- K972723 — BIO TROL
- K972487 — EMG RETRAINER
- K970051 — MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
- K943535 — MODEL ME 300 MUSCLE TESTER
- K963202 — MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
- K965006 — AT 62 EEG (A.K.A THE A; PHA-THETA TRAINER)
- K961645 — MRS-2D
- K961718 — DEI MODEL 20 EEG
- K960761 — PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
- K954737 — SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
- K960762 — SYNERGY PLUS
- K952797 — AT53 DUAL CHANNEL EMG
- K924313 — DIGITAL CONDUCTANCE METER
- K953257 — ORALSENSOR
- K954127 — BIOFEEDBACK DEVICE
- K951213 — RELAXPLUS
- K944615 — A620 EEG
- K945286 — THE BAGNOLI-2 EMG SYSTEM
- K942769 — BIOINTEGRATOR, BIOINTEGRATOR PLUS
- K945826 — J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
- K951350 — MUSCLESENSE ELECTROMYOGRAPHY DEVICE
- K941959 — VERSATELL; VERSATELL-S
- K951969 — MYOEXORCISER II FUAL
- K930578 — AT33 EMG
- K930576 — AT42
- K930577 — AT64 SCR
- K940050 — FOCUS EMG
- K920038 — NEUROSEARCH-4
- K925750 — RELAXOMAT
- K935853 — EMG TRAINER
- K922270 — PHYSIOTECH 4000 OR NORODYN 8000
- K941938 — THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
- K914925 — MEDAC SYSTEM/3
- K922838 — NORODYN 2000 ELECTROMYOGRAPH
- K925197 — PSI 220 DUAL EMG
- K914920 — BIOFEEDBACK SYSTEM/3
- K915858 — MYOTRAC2
- K915859 — MYOTRAC/S, MYODAC/S
- K913898 — MYOTRAC+/S, MYODAC+/S
- K911911 — MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
- K912595 — AXIOM ELECTROMYOGRAPH
- K897132 — PATHWAY II ELECTROMYOGRAPH
- K905372 — MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
- K905373 — MINIATURE TEMPERATURE TRAINER MODEL DT-002
- K903497 — FLEXCOMP DSP & PROCOMP
- K902450 — BODYLOG ENHANCED STRESS REDUCTION PACKAGE
- K896409 — M(3):MICRO MUSCLE MONITOR
- K900639 — DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
- K895635 — MYOSYSTEM 1000 ELECTROMYOGRAPH
- K895633 — MYOTRACE 10 BIOFEEDBACK DEVICE
- K894510 — BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
- K890500 — ELT OR ERGONOMIC LIFT TRAINER
- K892649 — VERIMED MYOEXORCISER III (MYO III)
- K892114 — ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
- K894840 — MYODAC2 BIOFEEDBACK DEVICE
- K891693 — AUTOMATED THERAPY SYSTEM
- K881164 — LEUNOMED RFB 5000
- K884849 — BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
- K884851 — BIOFEEDBACK DEVICE TG3, TG4
- K884848 — BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
- K884850 — BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
- K884852 — BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
- K884853 — BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
Data sourced from openFDA. This site is unofficial and independent of the FDA.