Home / 510(k) Clearances / K153054

510(k) K153054

N5-1 by Nuga Medical Co., Ltd. — Product Code JFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
October 20, 2015
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 Nuga Medical Co., Ltd.

  • K240168 — N7-S (September 12, 2024)
  • K111329 — NM-7000 (September 6, 2011)

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)
  • K140592 — CERAGEM AUTOMATIC THERMAL MASSAGER (December 17, 2014)
  • K111588 — LEGACY-500 (October 26, 2012)