3-D PASSIVE MOBILIZER— 510(k) K834360

Name: FDA 510(k) clearance K834360
Creator: U.S. Food and Drug Administration
Published: 1984-01-13

Substantially Equivalent

3-D Orthopedic, Inc.

FDA 510(k) clearance K834360 for 3-D PASSIVE MOBILIZER, Substantially Equivalent on 1984-01-13. Applicant: 3-D Orthopedic, Inc.. Device class: 2.

Clearance details

Applicant: 3-D Orthopedic, Inc.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1983-12-13
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISD

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K183296 — REAL Immersive System2019-03-18
K143512 — ActiSpec Activity Monitor2015-08-26
K112121 — ERGOSELECT/GE2012-10-31
K080545 — ACTITRAINER2008-07-24

Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.