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510(k) K240168

N7-S by Nuga Medical Co., Ltd. — Product Code JFB

K240168 is an FDA 510(k) premarket notification submitted by Nuga Medical Co., Ltd. for the device "N7-S". The FDA issued a decision of Substantially Equivalent on September 12, 2024. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Nuga Medical Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2024
Date Received
January 22, 2024
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.

  • K153054 — N5-1 (February 5, 2016)
  • 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)
  • 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)
  • K111588 — LEGACY-500 (October 26, 2012)

FDA data resources