Home / 510(k) Clearances / K930259

510(k) K930259

TRACTION TABLE MODEL #825-200 by Biodan Medical Systems, Ltd. — Product Code JFB

K930259 is an FDA 510(k) premarket notification submitted by Biodan Medical Systems, Ltd. for the device "TRACTION TABLE MODEL #825-200". The FDA issued a decision of Substantially Equivalent on March 24, 1993. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Biodan Medical Systems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1993
Date Received
January 19, 1993
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 Biodan Medical Systems, Ltd.

  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K930262 — TREATMENT TABLE, MODEL #825-100 (March 29, 1993)
  • K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (February 12, 1993)
  • K926082 — CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT (December 30, 1992)
  • K922591 — UROLOGICAL C-ARM TABLE, MODEL #056-450 (November 27, 1992)
  • K922605 — TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 (October 20, 1992)
  • K922604 — DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE (October 20, 1992)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)

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