Cleared Traditional

K821836 - PREGNANCY (W) EDGE (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K821836 · Body Therapeutics, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
38d
Days
Class 1
Risk

K821836 is an FDA 510(k) clearance for the PREGNANCY (W) EDGE. Classified as Orthosis, Truncal, Pregnancy (product code QSB), Class I - General Controls.

Submitted by Body Therapeutics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 890.3490 - the FDA obstetrics and gynecology 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 Body Therapeutics, Inc. devices

Submission Details

510(k) Number K821836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 30, 1982
Days to Decision 38 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 160d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSB Orthosis, Truncal, Pregnancy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
Definition Provide Abdominal And Back Support During Pregnancy
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.