Shokz Health Global Limited (specification developer, Kowloon, HK): 1 new FDA device listing, incl. hearing aid, bone conduction
Shokz Health Global Limited (Kowloon): 1 new FDA device listing, incl. hearing aid, bone conduction. Its amount of 1 is above the median of 2 (50th percentile). Dated 56 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 33 related HK DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Shokz Health Global Limited |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device |
| Location | Kowloon, HK |
| New listings | 1 |
| Devices | Hearing Aid, Bone Conduction |
| Product codes | LXB |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Bone conduction hearing aid |
| First new listing | 2026-09-11 |
| Latest new listing | 2026-09-11 |
| FDA registration number | 3049809193 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (34 HK records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Shokz Health Global Limited
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Shokz Health Global + all 34 HK records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (HK first): Soher Med Limited (foreign exporter, Hong Kong, HK) · Soher Med Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Worldwide Supplies Limited (foreign exporter, Hong Kong, HK) · Yizur Ltd (foreign exporter, Hong Kong, HK) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Shokz Health Global Limited and 34 HK peers
- HK DeviceEstablishmentPulse records like this one: 34
- Shokz Health Global Limited's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HK peer: $6,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Shokz Health Global Limited in Kowloon?
Shokz Health Global Limited (Kowloon, HK), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-09-11.
How does Shokz Health Global Limited compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 56 days old; check the official source for later updates before acting.
Shokz Health Global Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shokz Health Global Limited | Kowloon, HK | 1 | 50th | 2026-09-11 |
| Centinel Spine, LLC | West Chester, PA | 3 | 77th | 2026-10-22 |
| TORNIER Inc. | Columbia City, IN | 3 | 77th | 2026-10-21 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment
How to monitor Shokz Health Global Limited and peer specification developer (outsources manufacturing) records
Get new DeviceEstablishmentPulse records like Shokz Health Global Limited by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.