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Sign in to claim this brandRENU MEDICAL, INC
US
Last updated May 23, 2026
What RENU MEDICAL, INC makes
The company manufactures reprocessed medical devices including multi-chamber venous compression garments for deep vein thrombosis (DVT) prevention, electrocardiographic lead sets for ECG monitoring, and pneumatic tourniquet systems for surgical use. It also produces single-use items like manual intravenous pressure infusors and pulse oximeter probes, as well as patient mobility aids such as sliding transfer mats and repositioning sheets with pressure/vibration sensors.
These devices are classified under FDA regulations as Class I (general controls) or Class II (special controls), with some listed in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does RENU Medical, Inc. manufacture?
RENU Medical, Inc. specializes in reprocessed and single-use medical devices. Their most common products include multi-chamber venous compression garments (like DVT sleeves) for preventing deep vein thrombosis, electrocardiographic lead sets for ECG monitoring, and surgical pneumatic tourniquet systems. They also produce patient mobility aids such as sliding transfer mats and repositioning sheets with pressure/vibration sensors, as well as manual intravenous pressure infusors and pulse oximeter probes.
Where is RENU Medical, Inc. based?
RENU Medical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.
Which regulatory registries list RENU Medical, Inc.’s devices?
RENU Medical, Inc.’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track devices that require special controls (Class II) or general controls (Class I) under FDA regulations, ensuring transparency in their classification and compliance.
How are RENU Medical, Inc.’s devices classified under FDA regulations?
RENU Medical, Inc.’s devices fall under either Class I or Class II classifications. Class I devices, like some patient transfer mats, typically require general controls (e.g., good manufacturing practices). Class II devices, such as reprocessed ECG leads or tourniquet systems, involve additional special controls due to higher risk or complexity, necessitating pre-market submissions like 510(k)s for certain products.
Why do some of RENU Medical, Inc.’s devices appear in the FDA’s 510(k) registry?
The FDA’s 510(k) registry includes devices that require a premarket notification submission to demonstrate substantial equivalence to a legally marketed predicate device. Reprocessed items like ECG leads or tourniquet systems may appear here because their reprocessing methods or modifications could introduce risks requiring validation, ensuring patient safety and regulatory compliance before market distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 100439103
Catalogue (238)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HoverTech Lateral Transfer Mat | RM-HM50SPU-B | FDA UDI | Class I | Active |
| ECG Lead | RM-LW-341DS50/5A | FDA UDI | Class II | Active |
| HoverSling Repositioning Sheet | RM-HMSLING-39RS-B | FDA UDI | Class I | Active |
| Covidien DVT Sleeve | RM-9529 | FDA UDI | Class II | Active |
| Stryker Tourniquet | RM-5921-034-235 | FDA UDI | Class I | Active |
| Advantage Medical Cable ECG Leads | RM-LWM-341DS50/5A | FDA UDI | Class II | Active |
| Covidien ECG Leads | RM-33133 | FDA UDI | Class II | Active |
| AirPal Repositioning Sheet | RM-AP-050SPS | FDA UDI | Class I | Active |
| Covidien ECG Leads | RM-33105 | FDA UDI | Class II | Active |
| Navina Inserts | 69301 | FDA UDI | Class II | Active |
| Zimmer Tourniquet | RM-60-7080-103 | FDA UDI | Class I | Active |
| CTC DVT Sleeve | RM-VP-520L | FDA UDI | Class II | Active |
| Currie Healthcare DVT Sleeve | RM-ALP1SM | FDA UDI | Class II | Active |
| HoverTech Lateral Transfer Mat | RM-HM34SPU-B | FDA UDI | Class I | Active |
| Zimmer Tourniquet | RM-60-7070-106-00 | FDA UDI | Class I | Active |
| Covidien DVT Sleeve | RM-9780 | FDA UDI | Class II | Active |
| Nellcor Pulse Oximeter Probe | RM-MAX-AL | FDA UDI | Class II | Active |
| Zimmer Tourniquet | RM-60-7075-104-00 | FDA UDI | Class I | Active |
| Masimo Pulse Oximeter Probe | RM-2329 | FDA UDI | Class II | Unknown |
| HoverTech Lateral Transfer Mat | RM-HM39SPU-B | FDA UDI | Class I | Active |
| Zimmer Tourniquet | RM-60-7075-107 | FDA UDI | Class I | Active |
| Zimmer Tourniquet | RM-60707500700 | FDA UDI | Class I | Active |
| Philips ECG Lead | RM-989803192141 | FDA UDI | Class II | Active |
| Advantage Medical Cable ECG Leads | RM-LW-209DS50/3A | FDA UDI | Class II | Active |
| Covidien ECG Leads | RM-33136R36 | FDA UDI | Class II | Active |
| Ethox | RM-4010H | FDA UDI | Class I | Active |
| Medline DVT Sleeve | RM-MDS601MD | FDA UDI | Class II | Active |
| HoverMatt Lateral Transfer Mattress | RM-HM34SPU-LNK-B | FDA UDI | Class I | Active |
| Renu Medical Oximetry Sensor, Adult, Ped, Inf, Neo | K081927 | FDA 510(k) | Class II | Active |
| Renu Reprocessed Nellcor Oxysensor, Models D-20 And I-20 | K063661 | FDA 510(k) | Class II | Active |
| Renu Medical Reporcessed Compressible Limb Sleeves | K031559 | FDA 510(k) | Class II | Active |
| Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments | K093658 | FDA 510(k) | Class II | Active |
| Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme | K121145 | FDA 510(k) | Class II | Active |
| Renew Insert | K122003 | FDA 510(k) | Class II | Active |
| Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant And Neonate | K111773 | FDA 510(k) | Class II | Active |
| Renu Medical Reprocessed Alp 1 Calf Garment, Model Alp1 | K051227 | FDA 510(k) | Class II | Active |
| Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25 | K072194 | FDA 510(k) | Class II | Active |
| Reprocessed Tri Pulse Compression Garment | K203847 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Renewmedical Co., Ltd. Bucheon-si, Gyeonggi-do · KR FEI 3018799047