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510(k) K912348

SX90 (TM),MODEL 4800S by Medical Devices, Inc. — Product Code GZJ

K912348 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "SX90 (TM),MODEL 4800S". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
May 28, 1991
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 Medical Devices, Inc.

  • K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (February 5, 2001)
  • K930084 — MICRO-ARTHROSCOPE (September 1, 1995)
  • K943126 — ELECTROFLEX (December 5, 1994)
  • K940012 — SMARTBRACE ELECTRODE (December 5, 1994)
  • K935132 — HOME MICROCURRENT HMC (March 14, 1994)
  • K934619 — FLEXMATE (February 23, 1994)
  • K924897 — XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 (July 6, 1993)
  • K930053 — VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (May 17, 1993)
  • K923914 — IF-II (TM), MODEL 7200 (November 6, 1992)
  • K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (July 21, 1992)

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