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510(k) K823511

EMG BIOFEEDBACK DEVICE by Nemectron Medical, Inc. — Product Code HCC

K823511 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "EMG BIOFEEDBACK DEVICE". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1983
Date Received
November 29, 1982
Clearance Type
Traditional
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 Nemectron Medical, Inc.

  • K923396 — THERMODYN (May 26, 1993)
  • K895000 — NEMECTRON MICROWAVE (July 27, 1990)
  • K862376 — NEMECTROSON MODEL 2 (July 23, 1986)
  • K854720 — NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. (March 10, 1986)
  • K854721 — NEMECTRODYN MODEL 2 & ENDOVAC 2 (March 6, 1986)
  • K844416 — THERMOPULS E (March 12, 1985)
  • K843734 — NEMDI (October 25, 1984)
  • K843735 — SOFTEPIL (October 25, 1984)
  • K820334 — NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV (March 15, 1982)
  • K810513 — ELECTRODYN CII-INTERFERENTIAL MUSCLE (May 11, 1981)

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