HAND THERAPY ASSOST— 510(k) K933418

Substantially Equivalent

Bardon Ent., Inc.

FDA 510(k) clearance K933418 for HAND THERAPY ASSOST, Substantially Equivalent on 1994-04-28. Applicant: Bardon Ent., Inc.. Device class: 1.

Clearance details

Applicant: Bardon Ent., Inc.
Product code: Code JFA
Device class: Class 1
Regulation: 21 CFR 890.5410
Advisory panel: Physical Medicine
Date received: 1993-07-13
Decision date: 1994-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFA

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K931016 — JACE MODEL H440 HAND CPM DEVICE1994-06-22
K921351 — JACE MODEL PM-410 HAND CPM DEVICE1992-05-04
K900794 — MOBILIMB H3 HAND CPM UNIT1990-03-02
K900581 — DANNIFLEX CPM 880(TM)1990-02-20

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