RegenOMedix · Shockwave
PulseWave Elite Pro Focused Shockwave
A focused ESWT platform that concentrates acoustic energy at a set depth, up to 75 mm, for deeper musculoskeletal targets.
RegenOMedix
MedGeneRx HP15 PRP Kit
An FDA 510(k)-cleared Class II kit for preparing autologous PRP at the point of care from 15 mL of whole blood in a single spin.
FDA-cleared device. Per the manufacturer, this device is FDA-cleared. Use per its cleared indications.
Common in: Orthopedics · Aesthetics & hair restoration · Wound care · Sports medicine
Key facts
- Single spin of 15 mL whole blood gives 3 mL high-concentration and 5 mL mid-concentration PRP
- Integrated anticoagulant; vacutainer collection
- Works with existing 30 mm-diameter centrifuges
- Accessory kit included
Training & certification
PRP-X+ LifeLift™ Training & Certification from My Medical Training, RegenOMedix's training partner in Boca Raton, FL, covers PRP & PRF alongside shockwave, exosomes, ultrasound guidance, and practice marketing, with live demonstrations and a certificate of completion. An optional hands-on Day Two is available for licensed injectors.
A certificate of completion does not expand licensure or scope of practice. Confirm dates, tuition, and eligibility with My Medical Training.
Downloads & documents
Specifications
| Clearance | FDA 510(k), Class II |
|---|---|
| Platelet concentration | 4.1–4.5× baseline at 0 hr; 4.5–4.8× at 1 hr |
| RBC / HCT | 0.01 / 0.01% |
| pH | 7.5 at 0 hr |
From RegenOMedix materials. Confirm current specs and IFU before use.
Studies & evidence
Tap a study for the findings, limits, and source.
Bench / 510(k)RegenOMedix
MedGeneRx HP15 510(k) equivalence testing
Not stated
Platelet concentration factor was 4.1–4.5× baseline at 0 hours and 4.5–4.8× at 1 hour, with 61% platelet recovery at 1 hour, RBC 0.01, and pH 7.5.
Limits: Lab performance data, not clinical outcomes. Sample size not stated on the sales sheet.
MedGeneRx HP15 sales sheet.
Source document
About RegenOMedix
Regenerative device and topical partner (Zizion Group): PulseWave shockwave, MedGeneRx PRP, NanoPen microneedling, red light therapy, EleveXo exosome topicals, and BioFusion serums. Clinical training and certification are available through its training partner, My Medical Training.
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