Home / 510(k) Clearances / K834519

510(k) K834519

CALMTONE by Thought Technology , Ltd. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
December 21, 1983
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 Thought Technology , Ltd.

  • K213197 — MyOnyx System (June 17, 2022)
  • K201014 — MyOnyx System (January 13, 2021)
  • K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR (March 15, 2006)
  • K053266 — MYOTRAC INFINITI (December 29, 2005)
  • K925681 — MYOTRAC2D/CS (September 29, 1995)
  • K932149 — THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE (May 11, 1995)
  • K935213 — INCONTROL (May 11, 1995)
  • K915858 — MYOTRAC2 (September 9, 1992)
  • K915859 — MYOTRAC/S, MYODAC/S (September 9, 1992)
  • K913898 — MYOTRAC+/S, MYODAC+/S (March 26, 1992)

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)