Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin
FDA 510(k) K012614 · Medical Instruments Technology, Inc.
510(k) numberK012614
Submission
- Device name
- Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin
- Applicant
- Medical Instruments Technology, Inc.
St. George, UT, US - Received
- August 13, 2001
- Decision date
- May 1, 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
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|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K012640 | Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsHRX · Traditional | 02/28/2002SE |
| K012624 | Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited…HRX · Traditional | 11/08/2001SE |
| K012632 | Tourniquet Cuff; Pneumatic TourniquetKCY · Traditional | 10/26/2001SE |
| K884611 | The Orthoranger II Electronic GoniometerKQX · Traditional | 01/31/1989SE |
Questions and answers
When was Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin cleared by the FDA?
Kendall, Sequential Compression Device; Huntleigh, Flowtron; Venaflow; Acufex; Alps; Sheepskin (K012614) received a 510(k) decision of Substantially Equivalent on May 1, 2002, 261 days after the submission was received.
What is the product code of K012614?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.