Reprocessed Compression Sleeves
FDA 510(k) K100909 · Ascent Healthcare Solutions
510(k) numberK100909
Submission
- Device name
- Reprocessed Compression Sleeves
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- April 1, 2010
- Decision date
- July 23, 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 |
|---|---|---|
| K111600 | Reprocessed Hand Activate Sealer/DividerNUJ · Traditional | 11/15/2011SE |
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | 05/28/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
| K081238 | Reprocessed Masimo Pulse Oximeter SensorsNLF · Traditional | 07/29/2008SE |
Questions and answers
When was Reprocessed Compression Sleeves cleared by the FDA?
Reprocessed Compression Sleeves (K100909) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 113 days after the submission was received.
What is the product code of K100909?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.