PainChek (PainChek Adult)
FDA 510(k) clearance DEN240073 · decided 2025-10-06
Clearance details
- K-number
- DEN240073
- Device name
- PainChek (PainChek Adult)
- Applicant
- Painchek Limited (Ltd.)
- Decision
- Unknown
- Date received
- 2024-12-11
- Decision date
- 2025-10-06
- Days to decision
- 299 days
- Clearance type
- Direct
- Product code
- SGB
- Device class
- 2
- Regulation number
- 882.1472
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sydney, AU
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Painchek Limited (Ltd.)
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.