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510(k) K945954

MODELS 4100 AND 4300 MULTITHERAPY by Spinalight, Inc. — Product Code JFB

K945954 is an FDA 510(k) premarket notification submitted by Spinalight, Inc. for the device "MODELS 4100 AND 4300 MULTITHERAPY". The FDA issued a decision of Substantially Equivalent on January 19, 1995. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Spinalight, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1995
Date Received
December 6, 1994
Clearance Type
Traditional
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 Spinalight, Inc.

  • K172536 — Atlas Percussion Adjusting Instrument (June 20, 2018)
  • K001476 — TORQUE INSTRUMENT, MODEL 8500 (August 4, 2000)
  • K955540 — HAND HELD ATLAS INSTRUMENT (March 4, 1996)
  • K946258 — MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (November 20, 1995)
  • K933621 — HILO TABLE (January 7, 1994)
  • K933622 — FLEXION DISTRACTION TABLE (January 7, 1994)

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