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510(k) K063034

AIR-FLEX WITH AUTO-DISTRACTION by Hill Laboratories Co. — Product Code JFB

K063034 is an FDA 510(k) premarket notification submitted by Hill Laboratories Co. for the device "AIR-FLEX WITH AUTO-DISTRACTION". The FDA issued a decision of Substantially Equivalent on December 14, 2006. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Hill Laboratories Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2006
Date Received
October 3, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Physical Therapy, Multi Function
Device Class
Class II
Regulation Number
890.5880
Review Panel
PM
Submission Type

Other clearances by Hill Laboratories Co.

  • K090250 — ELECTRO-LIGHT THERAPY (February 11, 2010)
  • K083183 — AKLARUS PHOTOTHERAPY SYSTEM (July 16, 2009)
  • K072256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM W (March 12, 2008)
  • K062256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM (February 26, 2007)
  • K043239 — HEALTHSTAR ELITE (December 22, 2004)
  • K952357 — THE HILL ADJUSTABLE PODIATRY MODEL (July 6, 1995)
  • K942109 — THE HILL ADJUSTABLE RATH MECHANICAL TABLE (June 22, 1995)
  • K952358 — THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE (June 22, 1995)
  • K942256 — THE HILL ADJUSTABLE EXTEND-R TABLE (June 22, 1995)
  • K952355 — THE HILL ADJUSTABLE 90MD (June 22, 1995)

Other clearances for product code JFB

  • K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401) (July 11, 2025)
  • K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (January 31, 2025)
  • K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (January 8, 2025)
  • K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902) (November 27, 2024)
  • K240168 — N7-S (September 12, 2024)
  • K220572 — Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (June 17, 2022)
  • K202937 — Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (March 18, 2021)
  • K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (March 2, 2021)
  • K153054 — N5-1 (February 5, 2016)
  • K140592 — CERAGEM AUTOMATIC THERMAL MASSAGER (December 17, 2014)

FDA data resources