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510(k) K161628

JAS Pulse(TM) Ultrasonic Therapy by Bonutti Research, Inc. — Product Code IMI

K161628 is an FDA 510(k) premarket notification submitted by Bonutti Research, Inc. for the device "JAS Pulse(TM) Ultrasonic Therapy". The FDA issued a decision of Substantially Equivalent on November 10, 2016. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Bonutti Research, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
June 13, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Bonutti Research, Inc.

  • K093078 — UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS (June 23, 2010)
  • K090175 — UNITY BETA PLLA SYSTEM (September 10, 2009)
  • K082906 — UNITY BETA ANCHOR SYSTEM (October 30, 2008)
  • K062820 — UNITY ALPHA SYSTEM (March 15, 2007)
  • K060283 — TRANSET SYSTEM (February 22, 2006)
  • K052799 — MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (December 16, 2005)
  • K033717 — TRANSET FRACTURE FIXATION SYSTEM (February 25, 2004)
  • K013177 — MULTITAK SUTURE SNAP SYSTEM (December 19, 2001)
  • K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (October 29, 2001)
  • K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (May 8, 2001)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K160075 — Accent XL (August 17, 2016)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)

FDA data resources