Every TITN device is mapped to its FDA regulatory tier, its coverage position, and the peer-reviewed literature behind it. The 510(k) records, CMS coverage references, and DOIs are all linked below. Credibility you can check, not claims you have to trust.
FDA 510(k) cleared (K213900) for acquisition, display, and storage of EEG and event-related potentials to aid in diagnosis, not to diagnose any condition on its own. Used for quantified brain measures and longitudinal baseline-to-retest tracking; the clinician interprets.
K213900 · WAVi SCAN software, indicated for acquisition, display, and storage of EEG and event-related potentials to aid in diagnosis, not to diagnose any condition on its own.
Read your contractor's policy in the CMS Medicare Coverage Database before billing.
K162460 Research Desktop variant is not marketed.
Three-module integrated workstation, each module independently FDA 510(k) cleared. Manufactured by LD Technology. Covers autonomic function, sudomotor activity, and ankle-brachial index in one session, about ten minutes in our placements.
K173696 · Ankle-brachial index, pulse volume recording, plethysmography for PAD screening.
K200141 · SpO2, pulse rate, photoplethysmography waveform analysis, HRV, endothelial function analysis.
Pulse-wave cardiovascular screening at chairside; the manufacturer describes waveform pattern as an indicator of arterial flexibility. About one to three minutes in our placements, with an immediate report.
Pulse wave velocity and augmentation index are established vascular biomarkers described in the cardiology literature (Laurent S, et al., 2006, Expert consensus document on arterial stiffness: methodological issues and clinical applications, Eur Heart J; PubMed 17000623). We cite the device by its FDA 510(k) number (K110374) and do not claim device-specific validation studies beyond what the manufacturer or independent investigators have published.
FDA 510(k) cleared rTMS therapy for adults with Major Depressive Disorder who have failed prior antidepressants. Billed as a course of care when coverage criteria are met.
K220625 · ALTMS / BLOSSOM TMS, repetitive transcranial magnetic stimulation indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Coverage criteria per CMS LCD L34998 and billing article A57072.
The Hue Light USA suite operates exclusively under the FDA General Wellness policy for low-risk devices. These products are not FDA cleared. The peer-reviewed citations below describe the underlying mechanism research for each modality; they are not Hue Light-specific clinical claims.
Clinical-grade genetic testing delivered by PreCheckHealth Services. Four provider-ordered panels covering pharmacogenomics, hereditary cancer, immunogenetics, and adult neurogenetics.
10D2210020 · Clinical Laboratory Improvement Amendments certified for high-complexity testing.
9101993 · College of American Pathologists accredited laboratory.
All four panels are provider-ordered through PreCheckHealth, with genetic counseling available, scheduled by phone or email. PreCheckHealth bills insurance directly; TITN serves as a referral partner. The genetic data integrates with TITN's WAVi and TM-Flow records on the HIPAA-compliant patient portal.
Pharmacogenomics pairs cleanly with ALTMS treatment planning (psychiatric medication metabolism). The Neurogenetic Panel pairs with WAVi for genetic-plus-functional baseline assessment.
Every claim on this page is intended to trace to one of these source tiers, and estimates or directional data are marked where used. Report a claim you cannot verify to support@transitionitnow.com.
FDA 510(k) database (accessdata.fda.gov), CMS Physician Fee Schedule (PFS Look-Up), CMS Coverage Database (LCDs, NCDs, articles), peer-reviewed citations via PubMed and DOI.
Device IFUs, manufacturer regulatory pages (LD Technology, WAVi Co, REMED), Hue Light USA technical specifications. Used for device specs, not for clinical efficacy claims.
The TITN Forbidden Claims sheet lives in our internal regulatory documentation. Highlights are surfaced under each device above. Examples: WAVi does not diagnose; it records EEG and ERP measures a clinician interprets. TM-Flow modules are cited individually by K-number rather than collapsed, and Hue Light products operate exclusively under General Wellness scope.
Coverage references and Medicare PFS rates on this page are reference points only. Actual reimbursement varies by payer, plan, locality, and patient eligibility. CMS-published rates change annually. Verify locality-specific rates via the CMS PFS Look-Up before billing.
Live as of August 31, 2026. Next scheduled review: August 31, 2027. Spot a broken or outdated link? Email support@transitionitnow.com.
10D2210020 · College of American Pathologists accreditation 9101993 (verifiable via CMS CLIA Look-Up and CAP directory).Book a 15-minute call and we will walk through the evidence for the devices that fit your practice, with the reimbursement math worked out for your locality.
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