Cleared Traditional

K214037 - Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214037 · Ergo-Flex Technologies, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
791d
Days
Class 2
Risk

K214037 is an FDA 510(k) clearance for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Ergo-Flex Technologies, LLC (Conroe, US). The FDA issued a Cleared decision on February 22, 2024 after a review of 791 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Ergo-Flex Technologies, LLC devices

Submission Details

510(k) Number K214037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2021
Decision Date February 22, 2024
Days to Decision 791 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
676d slower than avg
Panel avg: 115d · This submission: 791d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Texas Applied Biomedical Services
M. Joyce Heinrich

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.