JACE MODEL PM-410 HAND CPM DEVICE— 510(k) K921351

Name: FDA 510(k) clearance K921351
Creator: U.S. Food and Drug Administration
Published: 1992-05-04

Substantially Equivalent

Jace Systems, Inc.

FDA 510(k) clearance K921351 for JACE MODEL PM-410 HAND CPM DEVICE, Substantially Equivalent on 1992-05-04. 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: 1992-03-19
Decision date: 1992-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorestown, NJ, US

Download summary PDF View on FDA.gov ↗

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K920380 — JACE MODEL W550 WRIST CPM DEVICE1992-02-11

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