AVACEN Medical’s Pain Relief Device With ‘Game Mode’ Wins FDA Clearance
AVACEN Medical said Wednesday that its first product, the AVACEN 100, has received 510(k) clearance from the FDA. The clearance allows AVACEN to market the device over the internet, without a prescription, for the temporary relief of joint pain stemming from arthritis, muscle spasms, minor strains and sprains.
The AVACEN 100 features a game mode that encourages users to complete their 10-to-30-minute therapy sessions, the San Diego, Calif., according to the company. The mode awards points when the user keeps their hand in the proper position on a hand pad during therapy, with more points awarded for better hand position. A display panel shows accumulated points and, if a patient’s hand drifts too far off target, an alarm sounds and 10,000 points are lost.
The final score is displayed at the end of the session, along with the users’ previous high score. AVACEN said the game also encourages the user with performance-related messages such as "Major league performance! Wow."
Spokesman Ryan Jeffcoat told Device Daily Bulletin that the game mode provides a way to help patients remain focused during treatment and maximize the device’s proper use. He sees the AVACEN 100 as the “tip of the iceberg” for this kind of technology.
The AVACEN 100 is available through the company’s website for $2,495. — Kellen Owings
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