FIRM-A-TRON— 510(k) K810634

Substantially Equivalent

Biotron , Ltd.

FDA 510(k) clearance K810634 for FIRM-A-TRON, Substantially Equivalent on 1981-06-12. Applicant: Biotron , Ltd.. Device class: 2.

Clearance details

Applicant: Biotron , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1981-03-10
Decision date: 1981-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)2026-06-02
K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241433 — EVE Synergy (EVE-20M)2025-06-04

More clearances from Biotron , Ltd.

K910135 — THE UNIVERSAL CEMENT PLUG(TM)1991-03-05
K843583 — FIRM-A-TRON MARK X1984-11-29
K780802 — ARMTROL AND FERMTROL1978-06-13
K780803 — TILL-U-TEST, DIP SLIDE1978-06-06

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