# K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089

- Pathway: 510(k) (Abbreviated)
- Applicant: Hygia Health Services, Inc.
- Decided: Dec 24, 2002 after 229 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Novamedix ImPadO: named in the summary without a submission number

## Most influential descendants
- K031559: Renu Medical Reporcessed Compressible Limb Sleeves (2003), 4 descendants of its own
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (2006), 3 descendants of its own
- K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 (2006), 2 descendants of its own
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K203847: Reprocessed Tri Pulse Compression Garment (2021), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed Novamedix ImPadB is designed to enhance circulation of blood. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: DVT prophylaxis Acute and chronic edema Extreme pain after trauma or surgery Treat leg ulcers and venous stasidinsuffici

Source page: https://510kreport.com/device/K021509
Methodology: https://510kreport.com/methodology