Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs
FDA 510(k) K090074 · Hygia Health Services, Inc.
510(k) numberK090074
Submission
- Device name
- Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs
- Applicant
- Hygia Health Services, Inc.
Birmingham, AL, US - Received
- January 12, 2009
- Decision date
- April 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
More from Manamed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…NMD · Traditional | 05/04/2010SE |
| K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…NLF · Traditional | 05/28/2008SE |
| K053575 | Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsJOW · Traditional | 02/15/2006SE |
| K041867 | Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-A, Hhs-Max-Al, Hhs-Max-NNLF · Traditional | 09/10/2004SE |
| K032821 | Hygia Health Services Reprocessed Blood Pressure CuffNPP · Traditional | 12/05/2003SE |
| K012715 | Hygia Health Services Reprocessed Nellcot D-25 Oxisensor IINLF · Traditional | 08/01/2003SE |
| K021509 | Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089JOW · Abbreviated | 12/24/2002SE |
| K012657 | Hygia Health Services Reprocessed Nutech Calf WrapJOW · Traditional | 04/12/2002SE |
| K012654 | Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20…JOW · Traditional | 04/12/2002SE |
| K012651 | Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200JOW · Traditional | 04/12/2002SE |
Questions and answers
When was Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs cleared by the FDA?
Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (K090074) received a 510(k) decision of Substantially Equivalent on April 22, 2009, 100 days after the submission was received.
What is the product code of K090074?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.