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510(k) K021755

APEX MEDICAL DIGITAL TENS TS1211, TS1212 by Apex Medical Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2002
Date Received
May 29, 2002
Clearance Type
Special
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 Apex Medical Corp.

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  • K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (October 6, 2014)
  • K121642 — WIZARD 230 NASAL PILOW MASK (June 6, 2013)
  • K112079 — APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (December 6, 2012)
  • K120035 — APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (May 16, 2012)
  • K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK (May 6, 2011)
  • K103535 — VACPLUS SUCTION UNIT (February 24, 2011)

Other clearances for product code GZJ

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  • 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)