Model 90022 Rolling Stand
FDA 510(k) K963672 · Augustine Medical, Inc.
510(k) numberK963672
Submission
- Device name
- Model 90022 Rolling Stand
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- September 13, 1996
- Decision date
- January 6, 1997
- 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 |
|---|---|---|
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | 07/09/2002SE |
| K020077 | Modification to Augustine Medical Wound Care System, Model 68XXXMSA · Special | 01/31/2002SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | 09/06/2000SE |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | 04/30/1998SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | 06/26/1997SE |
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | 12/29/1995SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
| K950416 | Bair Hugger Model 600 Unit, BlanketsDWJ · Traditional | 08/29/1995SE |
Questions and answers
When was Model 90022 Rolling Stand cleared by the FDA?
Model 90022 Rolling Stand (K963672) received a 510(k) decision of Substantially Equivalent on January 6, 1997, 115 days after the submission was received.
What is the product code of K963672?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.