Cleared Traditional

K870402 - MOBILIMB HAND EXERCISER

K870402 is an FDA 510(k) clearance for MOBILIMB HAND EXERCISER, manufactured by Biodynamic Technologies, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K870402 · Biodynamic Technologies, Inc. · Physical Medicine device
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Mar 1987
Decision
42d
Days
Class 1
Risk

K870402 is an FDA 510(k) clearance for the MOBILIMB HAND EXERCISER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine device framework. 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K870402

510(k) Number K870402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1987
Decision Date March 16, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 32
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K870402.
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