Home / 510(k) Clearances / K922270

510(k) K922270

PHYSIOTECH 4000 OR NORODYN 8000 by Myo-Tronics, Inc. — Product Code HCC

K922270 is an FDA 510(k) premarket notification submitted by Myo-Tronics, Inc. for the device "PHYSIOTECH 4000 OR NORODYN 8000". The FDA issued a decision of Substantially Equivalent on September 2, 1994. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Myo-Tronics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
May 14, 1992
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 Myo-Tronics, Inc.

  • K970116 — ESG-1 ELECTROSONOGRAM (ESG-1) (April 2, 1997)
  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)
  • K922456 — K6-I DIAGNOSTIC SYSTEM (June 9, 1994)
  • K921919 — MS-100 MYO-SCANNER OR MS-100 EMG SCANNER (January 7, 1993)
  • K905449 — ELECTROSONOGRAM ESG-1 (April 26, 1991)

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