Cleared Traditional

K791565 - PARAPODIUM

K791565 is an FDA 510(k) clearance for PARAPODIUM, manufactured by Physico-Medical Systems Corp.. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K791565 · Physico-Medical Systems Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
13d
Days
Class 1
Risk

K791565 is an FDA 510(k) clearance for the PARAPODIUM. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Physico-Medical Systems Corp. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1979 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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.

FDA 510(k) Submission Details - K791565

510(k) Number K791565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1979
Decision Date August 28, 1979
Days to Decision 13 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
103d faster than avg
Panel avg: 116d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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 - IQI Orthosis, Limb Brace

All 47
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K791565.
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · Fred Sammons, Inc. · Aug 1980
HUMEROUS FRACTURE BRACE, ULNA FRACTURE
K801788 · Hosmer Dorrance Corp. · Aug 1980
OHC DYNAMIC CLUB FOOT BRACE
K800715 · Ipos Luneburg · May 1980
SECUTE ELBOW BAND
K791248 · Conphar, Inc. · Jul 1979
SECUTEX WRIST BRACE
K791249 · Conphar, Inc. · Jul 1979
SECUTEX KNEE BAND
K791266 · Conphar, Inc. · Jul 1979
K791565 · PARAPODIUM
Download PDF Physico-Medical Syste…