Feel free to contact us.
Regulatory Status: The PureSpin is an FDA cleared 510 (K) Class II medical device. PureSpin PRP® is intended for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograph or allograft bone prior to application to an orthopedic surgical site. 510 (K ) number BK050055. The Rejuvapen® is marketed for and has an intended use for micro-pigmentation treatments. The Apex Magnum® has an intended use as a Therapeutic massager under Sec. 890.5660. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.The Rejuvapen NXT ® is marketed for and has an intended use as a micro-pigmentation treatments.
Copyright © 2018 Refine USA - All Rights Reserved.