REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE— 510(k) K925271

Name: FDA 510(k) clearance K925271
Creator: U.S. Food and Drug Administration
Published: 1993-03-31

Substantially Equivalent

Repex Intl., Inc.

FDA 510(k) clearance K925271 for REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE, Substantially Equivalent on 1993-03-31. Applicant: Repex Intl., Inc.. Device class: 1.

Clearance details

Applicant: Repex Intl., Inc.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1992-10-19
Decision date: 1993-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Plymouth New Zealand, NZ

Download summary PDF View on FDA.gov ↗

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