The product
A precision airway clearance device for choking emergencies.
lifewand generates a consistent, calibrated vacuum (~3.2 bar) on every activation — independent of user strength or state of mind. Unlike plunger-style devices, its built-in automatic mechanism delivers the same performance every time.
Built like medical equipment, not a toy.
Key specifications
| Vacuum output | ~3.2 bar (consistent, automatic) |
| Activation | Single-trigger, 3-step operation |
| Variants | 3 (Adult, Pediatric, Infant) |
| QMS standard | ISO 13485 (SII certified) |
| Performance std. | ISO 18190 |
| FDA registration | Registered establishment & device (No. 3015168845) |
| Emergency policy | Free replacement after real use |
Product variants
Three purpose-built devices — one per age group.
Each lifewand is calibrated specifically for its age group. Not a universal device with attachments — a dedicated instrument for each patient.
Adult
Ages 12 and over
Full mask geometry for adult facial anatomy. Maximum vacuum calibration for adult airway dimensions.
Pediatric
Ages 1–11
Smaller mask and calibrated vacuum level for children's airways. Optimised seal geometry for smaller faces.
Infant
Under 12 months
Smallest mask geometry with gentle vacuum calibration safe for infant airways and facial structure.
Regulatory status
Active submissions in three markets.
| Market | Framework | Status | Notes |
|---|---|---|---|
| 🇨🇦 Canada | Health Canada SOR/98-282 | Sold commercially | Available on Amazon Canada. Bilingual labeling (EN/FR). |
| 🇮🇱 Israel | AMAR Procedures 02 & 03 + DR 47 | Submission in progress | Technical file under preparation. ISO 13485 certified by SII (Israel). |
| 🇪🇺 EU / EEA | EU MDR 2017/745 | Submission in progress | CE marking process active. Technical documentation prepared per MDR Annex II/III. |
ISO 13485 certification covers our Quality Management System (SII — Standards Institution of Israel). Regulatory market approval claims are made only in markets where formal approval has been granted.
Why partner with lifewand
Built for serious distribution partnerships.
Exclusive territory
One committed partner per market. Territorial exclusivity protects your investment and ensures a long-term, collaborative relationship.
Full regulatory support
We supply all technical documentation, labeling, and regulatory files. You are not starting from zero — the work is done.
Proven commercial traction
ISO 13485 certified manufacturer. Tested to ISO 18190. A documented product with active regulatory submissions in three markets.
Company credentials
Extralife Ltd. — an Israeli medical device manufacturer.
Founded and registered in Israel. ISO 13485 certified by SII (Standards Institution of Israel). Clinical and regulatory expertise in EU MDR, Health Canada, and AMAR frameworks. Committed to expanding access to reliable airway clearance devices across global markets.
Ready to explore distribution in your market?
We welcome enquiries from serious distribution partners. Let’s start a conversation.
Email: marketing@lifewand.com
Web: lifewand.com