Cleared Traditional

CHIROPRACTIC ACTIVATOR OR PORT. CHIRO (K834137) - FDA 510(k) Clearance

K834137 · Rhode Island Chiropractic Pain Clinic · Physical Medicine device
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Jan 1984
Decision
44d
Days
-
Risk

K834137 is an FDA 510(k) clearance for the CHIROPRACTIC ACTIVATOR OR PORT. CHIRO.

Submitted by Rhode Island Chiropractic Pain Clinic (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rhode Island Chiropractic Pain Clinic devices

Submission Details

510(k) Number K834137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1983
Decision Date January 13, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -