PORTABLE ISOKINETICS 3004 KNEE UNIT— 510(k) K862996

Name: FDA 510(k) clearance K862996
Creator: U.S. Food and Drug Administration
Published: 1986-08-20

Substantially Equivalent

Kent Design & Manufacturing, Inc.

FDA 510(k) clearance K862996 for PORTABLE ISOKINETICS 3004 KNEE UNIT, Substantially Equivalent on 1986-08-20. Applicant: Kent Design & Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Kent Design & Manufacturing, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1986-08-08
Decision date: 1986-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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K862993 — PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT1986-08-20
K862994 — PORTABLE ISOKINETICS 3002 ISO KANE II1986-08-20
K862995 — PORTABLE ISOKINETICS 3003 SHOULDER UNIT1986-08-20
K862997 — PORTABLE ISOKINETICS 3005 HIP UNIT1986-08-20
K862998 — PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT1986-08-20

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