Home › Device types › JOW
Sleeve, Limb, Compressible
FDA product code JOW · Class 2 · Cardiovascular
2,563
Registered devices
1,705
Adverse events
32
Recalls
352
510(k) clearances
Devices with this code
Adult boot No. 2A RC-FLS — MEGO afek Agricultural Cooperative Society LtdAlbahealth — Albahealth, LLCVasoPress — COMPRESSION THERAPY CONCEPTS, INC.Flexitouch Plus — Tactile Systems Technology, Inc.nimbl — Tactile Systems Technology, Inc.AIROS — AIROS MEDICAL INCNA — STERILMED, INC.ThermoTek WRAP, KNEE,STD, HL, SPU, UF — THERMOTEK, INC.AIRCAST — DJO, LLCFlexitouch Plus — Tactile Systems Technology, Inc.Multi-FLO DVT Combo Cyro Knee Sleeve — Bio Compression Systems, IncTherm-X — ZENITH TECHNICAL INNOVATIONS, LLCBlue Boot — NORMATEC INDUSTRIES LPCovidien DVT Sleeve — RENU MEDICAL, INCMeridian Medical — COMPASS HEALTH BRANDS CORP.CapiFlo — K L Distributing Inc.Kendall SCD — Cardinal Health, Inc.Bio Compression Systems Bio Arterial Plus Model IC-BAP — Bio Compression Systems, IncAIROS — AIROS MEDICAL INCFlexitouch — Tactile Systems Technology, Inc.Cirona — OAKWELL DISTRIBUTION, INC.PulseFlow DF™ — PULSE FLOW TECHNOLOGIESFlexitouch Plus — Tactile Systems Technology, Inc.Lympha Press Optimal Plus(US) BT — MEGO afek Agricultural Cooperative Society Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-13 | Cardinal Health 200, LLC | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2025-05-13 | Cardinal Health 200, LLC | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2025-05-13 | Cardinal Health 200, LLC | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| 2023-04-14 | Stryker Sustainability Solutions | Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. |
| 2021-07-09 | Ortho8, Inc. | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |
| 2021-07-09 | Ortho8, Inc. | EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |
| 2019-04-08 | Compass Health Brands (Corporate Office) | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
| 2019-04-08 | Compass Health Brands (Corporate Office) | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
| 2019-04-08 | Compass Health Brands (Corporate Office) | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
| 2019-04-08 | Compass Health Brands (Corporate Office) | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
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