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510(k) K013399

MODEL MES-9000/EMG SYSTEM by Myotronics-Noromed, Inc. — Product Code HCC

K013399 is an FDA 510(k) premarket notification submitted by Myotronics-Noromed, Inc. for the device "MODEL MES-9000/EMG SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2001. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Myotronics-Noromed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2001
Date Received
October 15, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Myotronics-Noromed, Inc.

  • K111687 — EMG SYSTEM (September 29, 2011)
  • K040400 — MYO-TRODE SG DISPOSABLE ELECTRODE (July 20, 2004)
  • K031998 — MODEL J-5 MVO-MONITOR (July 24, 2003)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000 (August 13, 1999)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources