Cleared Traditional

K012657 - HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP

K012657 is an FDA 510(k) clearance for HYGIA HEALTH SERVICES REPROCESSED NUTEC..., manufactured by Hygia Health Services, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K012657 · Hygia Health Services, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
242d
Days
Class 2
Risk

K012657 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Hygia Health Services, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 242 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hygia Health Services, Inc. devices

FDA 510(k) Submission Details - K012657

510(k) Number K012657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date April 12, 2002
Days to Decision 242 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 324
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K012657.
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
K012651 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
K012654 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480
K012417 · Hygia Health Services, Inc. · Apr 2002
WIZAIR DVT
K012994 · Medical Compression Systems (Dbn) , Ltd. · Mar 2002