BX-1000 ISOMATIC— 510(k) K820080

Substantially Equivalent

Bloomex International, Inc.

FDA 510(k) clearance K820080 for BX-1000 ISOMATIC, Substantially Equivalent on 1982-07-01. Applicant: Bloomex International, Inc.. Device class: 2.

Clearance details

Applicant: Bloomex International, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1982-01-12
Decision date: 1982-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 7600 Ridge Blvd Brooklun, NY, 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 Bloomex International, Inc.

K942195 — BX-400S1995-08-14
K943185 — BX-200 SC1995-08-14
K842142 — BX-4001984-06-25
K841779 — ELECTRONIC MUSCLE EXERCISE EQUIPMENT1984-05-30
K832976 — BX-600 EMS1983-11-25

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