Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200
FDA 510(k) K012651 · Hygia Health Services, Inc.
510(k) numberK012651
Submission
- Device name
- Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200
- Applicant
- Hygia Health Services, Inc.
Birmingham, AL, US - Received
- August 13, 2001
- Decision date
- April 12, 2002
- 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 |
| K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsJOW · Traditional | 04/22/2009SE |
| 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 |
Questions and answers
When was Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 cleared by the FDA?
Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200 (K012651) received a 510(k) decision of Substantially Equivalent on April 12, 2002, 242 days after the submission was received.
What is the product code of K012651?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.