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Sign in to claim this brandWaisMed Ltd
US
Last updated May 30, 2026
What WaisMed Ltd makes
WaisMed Ltd manufactures intraosseous infusion kits, including models for pediatric use, designed for emergency medical procedures requiring rapid fluid administration into bone marrow. The company also produces first aid absorbent pads and bandages, as well as intravenous line stopcocks for medical fluid management. These products are intended for use in pre-hospital and clinical settings where quick, reliable access to vascular or intraosseous pathways is critical.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded under 510(k) and UDI (Unique Device Identification) listings. The portfolio is regulated under US medical device authorities, and the manufacturer 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 WaisMed Ltd manufacture?
WaisMed Ltd specializes in three primary device categories: intraosseous infusion kits (including pediatric models like the BONE INJECTION GUN for PEDIATRICS, MODEL 1ST), first aid absorbent pads/bandages, and intravenous line stopcocks. These devices are designed for emergency and clinical use, particularly where rapid fluid administration or secure vascular access is essential.
Where is WaisMed Ltd based, and how does that affect its regulatory oversight?
WaisMed Ltd is based in the United States, which means its devices are regulated under FDA authorities. The company’s products are classified as Class I or Class II, with submissions tracked through 510(k) premarket notifications and UDI listings—standard pathways for US-manufactured medical devices.
Which regulatory registries or databases list WaisMed Ltd’s devices?
WaisMed Ltd’s devices are recorded in the FDA’s 510(k) premarket submission database and the UDI (Unique Device Identification) system. These registries ensure traceability and compliance with US medical device regulations, allowing healthcare providers and regulators to verify device details and approval statuses.
How are WaisMed Ltd’s devices classified under FDA regulations?
WaisMed Ltd’s devices fall into two FDA classification tiers: Class I (generally low-risk, with minimal regulatory controls) and Class II (moderate-risk, requiring specific performance standards or post-market surveillance). The classification depends on factors like the device’s intended use (e.g., intraosseous infusion) and potential health impact, as outlined in FDA’s regulatory framework.
Why do some of WaisMed Ltd’s devices appear under multiple names (e.g., NIO, GOIO, B.I.G.)?
The repeated names like NIO (e.g., NIO-I, NIO Fixation) and GOIO reflect variations in model design, intended use, or technical specifications (e.g., pediatric vs. adult applications). For example, the BONE INJECTION GUN (B.I.G.) for PEDIATRICS is tailored for children, while other NIO models may serve broader or specialized emergency scenarios. These distinctions help clinicians select the right device for their procedure.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- persysmedical.com
- —
- —
- [email protected]
- Phone
- 1-888-737-7978
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 514619238
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nio | NIO-A | FDA UDI | Class II | Active |
| Nio | NIO-I | FDA UDI | Class II | Active |
| B.i.g. | B.I.G.- P | FDA UDI | Class II | Active |
| Nio | NIO Adult+ | FDA UDI | Class II | Active |
| Goio | GOIO | FDA UDI | Class I | Active |
| Nio | NIO-P | FDA UDI | Class II | Active |
| Goio | GOIO without Fixation | FDA UDI | Class I | Active |
| B.i.g. | B.I.G.- A | FDA UDI | Class II | Active |
| Nio | NIO-P | FDA UDI | Class II | Active |
| NIO Fixation | NIO Fixation | FDA UDI | Class I | Active |
| Bone Injection Gun (b.i.g.) For Pediatrics, Model 1st | K022415 | FDA 510(k) | Class II | Active |
| Nio-I | K190538 | FDA 510(k) | Class II | Active |
| Bone Injection Gun (b.i.g.) Device | K981853 | FDA 510(k) | Class II | Active |
| NIO+ Adult | K211968 | FDA 510(k) | Class II | Active |
| Bone Injection Gun (b.i.g.) | K062940 | FDA 510(k) | Class II | Active |
| Nio -intraosseous Device | K142086 | FDA 510(k) | Class II | Active |
| Nio-P | K160805 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Waismed Ltd. Rosh Haayin Central · IL FEI 3001316486