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510(k) K850642

TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA by Thought Technology , Ltd. — Product Code HCC

K850642 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA". The FDA issued a decision of Substantially Equivalent on May 17, 1985. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Thought Technology , Ltd. has 21 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
Feb 19, 1985
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
510(k) Exempt

Other clearances by Thought Technology , Ltd.

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

Other clearances for product code HCC

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

FDA data resources