Is this your brand? Sign in to claim ownership.
Sign in to claim this brandNSPIRE HEALTH, INC.
US
Last updated May 25, 2026
What NSPIRE HEALTH, INC. makes
The company manufactures devices for pulmonary function testing and respiratory diagnostics, including disposable and reusable mouthpieces, spirometry systems for adults, professional and mechanical monitoring spirometers, whole-body plethysmographs, reusable medicine chamber spacers, and manual peak flow meters. These products are designed to measure lung function, assess airflow obstruction, and monitor respiratory conditions in clinical and home settings.
The portfolio includes devices authorised as Class I and Class II under US regulations, with submissions recorded in the FDA’s 510(k) and UDI registries. The company operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
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 NSpire Health, Inc. manufacture?
NSpire Health, Inc. specializes in devices for pulmonary function testing and respiratory diagnostics. Their portfolio includes disposable and reusable mouthpieces, professional and mechanical spirometers, whole-body plethysmographs, reusable medicine chamber spacers, and manual peak flow meters. These devices are designed to measure lung function, diagnose airflow obstruction, and monitor respiratory conditions in both clinical and home settings.
Where is NSpire Health, Inc. based?
NSpire Health, Inc. is based in the United States. As a US-based manufacturer, their devices are developed and authorised in accordance with the regulatory requirements applicable to medical devices in that jurisdiction.
Which regulatory registries list NSpire Health, Inc.’s devices?
NSpire Health, Inc.’s devices are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track submissions for devices authorised as Class I and Class II under US regulations, ensuring transparency in their regulatory status.
How are NSpire Health, Inc.’s devices classified under US regulations?
NSpire Health, Inc.’s devices are authorised as either Class I or Class II under the US medical device classification system. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on the device’s intended use and potential risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 184817096
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| nSpire Health | KoKo Legend II | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Px 2000 Pulmonary Function Testing System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 2000 Pulmonary Function Test System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | Bronchial Challenge Kit, Disp | FDA UDI | Class I | Active |
| nSpire Health | KoKo Px 3000 Pulmonary Function Testing System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | BpD | FDA UDI | Class II | Active |
| nSpire Health | KoKo Sx 1000 Diagnostic Spirometer | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 3000 Pulmonary Function Testing System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Legend II | FDA UDI | Class II | Active |
| nSpire Health | Wright Respirometer Mk 8 | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 4000 Pulmonary Function Testing System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 4000N Pulmonary Function Testing System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| Hudson RCI | Pocket Peak Flow Meter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class II | Active |
| nSpire Health | Wright Respirometer Mk 14 | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter | FDA UDI | Class II | Active |
| nSpire Health | Wright Respirometer Haloscale Standard | FDA UDI | Class II | Active |
| Hudson RCI | Pocket Chamber | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 4000 Pulmonary Function Plethysmograph | FDA UDI | Class II | Active |
| nSpire Health | KoKo Px 4000 Pulmonary Function System | FDA UDI | Class II | Active |
| nSpire Health | KoKo Filter Kit | FDA UDI | Class I | Active |
| nSpire Health | KoKo Sx 1000 Diagnostic Spirometer Standalone Edition | FDA UDI | Class II | Active |
| Hudson RCI | Pocket Chamber | FDA UDI | Class II | Active |
| Wright Respirometer, Mark 8, And 14 Respirometer, Model 700-021, 700-008, 700-014 | K091853 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.