Home / 510(k) Clearances / K800630

510(k) K800630

TYPE 4000 TRANSCUTANEOUS ELEC. STIM. by Frye Electronics, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Frye Electronics, Inc.

  • K123701 — HEARLAB ACA (April 5, 2013)
  • K093006 — FONIX ,MODEL 8000 (December 30, 2009)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
  • K980377 — FONIX FP35 HEARING AID ANALYZER (March 18, 1998)
  • K935400 — FONIX 3500 HEARING AID ANALYZER (January 14, 1994)
  • K913221 — TYPE FA10 AUDIOMETER (October 11, 1991)
  • K895383 — TYPE FP40 DIGITAL HEARING AID ANALYZER (January 22, 1990)
  • K872242 — TYPE 6400 REAL EAR HEARING AID ANALYZER (July 10, 1987)
  • K861571 — TYPE 6500 HEARING AID ANALYZER (May 30, 1986)
  • K850918 — TYPE FP30 DIGITAL HEARING AID ANALYZER (May 29, 1985)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)