Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments
FDA 510(k) K093658 · Renu Medical, Inc.
510(k) numberK093658
Submission
- Device name
- Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments
- Applicant
- Renu Medical, Inc.
Everett, WA, US - Received
- November 25, 2009
- Decision date
- January 14, 2010
- 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 |
|---|---|---|
| K203847 | Reprocessed Tri Pulse Compression GarmentJOW · Traditional | 05/07/2021SE |
| K121145 | Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical…JOW · Traditional | 06/12/2012SE |
| K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateNLF · Traditional | 11/16/2011SE |
| K081927 | Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoNLF · Traditional | 02/06/2009SE |
| K072194 | Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25NLF · Traditional | 11/29/2007SE |
| K063661 | Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20NLF · Traditional | 05/25/2007SE |
| K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1JOW · Traditional | 04/07/2006SE |
| K031559 | Renu Medical Reporcessed Compressible Limb SleevesJOW · Traditional | 11/12/2003SE |
Questions and answers
When was Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments cleared by the FDA?
Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments (K093658) received a 510(k) decision of Substantially Equivalent on January 14, 2010, 50 days after the submission was received.
What is the product code of K093658?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.