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510(k) K070672

MASSAGE MATTRESS VM9100RM by Metek GmbH — Product Code JFB

K070672 is an FDA 510(k) premarket notification submitted by Metek GmbH for the device "MASSAGE MATTRESS VM9100RM". The FDA issued a decision of Substantially Equivalent on June 26, 2007. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Metek GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2007
Date Received
March 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Metek GmbH

  • K780800 — ELECTRONIC THERMOMETER (June 6, 1978)

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