Flowtron DVT System AC500 Pump, L501 Garment
FDA 510(k) K881632 · Huntleigh Technology, Inc.
510(k) numberK881632
Submission
- Device name
- Flowtron DVT System AC500 Pump, L501 Garment
- Applicant
- Huntleigh Technology, Inc.
Manalapan, NJ, US - Received
- April 14, 1988
- Decision date
- September 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K992733 | Akron ATP9 Traction MachineITH · Traditional | 11/10/1999SE |
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| K924516 | OP3/VP4HGL · Traditional | 06/28/1993SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K884451 | Dopcord PPGJOM · Traditional | 01/12/1989SE |
| K874688 | Flowtron AC200/2IRP · Traditional | 09/23/1988SE |
| K882644 | Huntleigh Double Bubble AIR-O-PAD-AOP5FNM · Traditional | 08/10/1988SE |
Questions and answers
When was Flowtron DVT System AC500 Pump, L501 Garment cleared by the FDA?
Flowtron DVT System AC500 Pump, L501 Garment (K881632) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 165 days after the submission was received.
What is the product code of K881632?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.