BODYFLEX MASSAGER— 510(k) K952041

Name: FDA 510(k) clearance K952041
Creator: U.S. Food and Drug Administration
Published: 1995-08-14

Substantially Equivalent

Truro'S Ent.

FDA 510(k) clearance K952041 for BODYFLEX MASSAGER, Substantially Equivalent on 1995-08-14. Applicant: Truro'S Ent.. Device class: 1.

Clearance details

Applicant: Truro'S Ent.
Product code: Product code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1995-05-01
Decision date: 1995-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egina, Saskatchewan, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISA

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K221865 — BTL-0942023-04-14
K210166 — Omnispec ED10002023-01-27
K213120 — OW100S (model OW100S-US)2022-10-12

Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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