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510(k) K831147

OMNIPROBE ELECTRICAL NERVE STIMULATOR by Omni Intl., Inc. — Product Code GZJ

K831147 is an FDA 510(k) premarket notification submitted by Omni Intl., Inc. for the device "OMNIPROBE ELECTRICAL NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Omni Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
April 8, 1983
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 Omni Intl., Inc.

  • K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM (January 13, 1999)
  • K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE (January 8, 1999)
  • K853255 — OMNIMED I.V. SOLUTION ADMIN. SET (August 23, 1985)
  • K851938 — OMNIMED SURGICAL GOWN (June 28, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR (May 23, 1985)
  • K850706 — F-SERIES IMPLANT (April 10, 1985)
  • K850112 — OMNIMED IV SOLUTION ADMINISTRATION SET (February 22, 1985)
  • K850066 — OMNIMED NASAL OXYGEN CANNULA (January 24, 1985)
  • K821523 — OMNI TENS (June 16, 1982)

Other clearances for product code GZJ

  • K252712 — STIMPOD NMS460 Nerve Stimulator (May 28, 2026)
  • 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)

FDA data resources