JACE MODEL H440 HAND CPM DEVICE— 510(k) K931016

Name: FDA 510(k) clearance K931016
Creator: U.S. Food and Drug Administration
Published: 1994-06-22

Substantially Equivalent

Jace Systems, Inc.

FDA 510(k) clearance K931016 for JACE MODEL H440 HAND CPM DEVICE, Substantially Equivalent on 1994-06-22. Applicant: Jace Systems, Inc.. Device class: 1.

Clearance details

Applicant: Jace Systems, Inc.
Product code: Code JFA
Device class: Class 1
Regulation: 21 CFR 890.5410
Advisory panel: Physical Medicine
Date received: 1993-02-26
Decision date: 1994-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorestown, NJ, US

Download summary PDF View on FDA.gov ↗

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K900794 — MOBILIMB H3 HAND CPM UNIT1990-03-02
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K922185 — JACE KNEE EXTENSION SYSTEM -- MODIFICATION1992-06-11
K920380 — JACE MODEL W550 WRIST CPM DEVICE1992-02-11

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