ACUDATA INDICATENS MODEL 5X— 510(k) K890088

Substantially Equivalent

Acudata Software

FDA 510(k) clearance K890088 for ACUDATA INDICATENS MODEL 5X, Substantially Equivalent on 1989-05-26. Applicant: Acudata Software. Device class: 2.

Clearance details

Applicant: Acudata Software
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1989-01-10
Decision date: 1989-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Acudata Software

K900596 — ACUDATA INDICATENS MODEL 5A1990-06-22
K900668 — ACUDATA INDICATENS MODEL 5XS1990-06-22
K890087 — ACUDATA INDICATENS MODEL 5M1989-09-07
K891105 — INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES1989-05-25
K891107 — INDICATENS INDICATOR ELECTRODE MODEL 21989-05-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.