510(k) DEN170028
DEN170028 is an FDA 510(k) premarket notification submitted by Cala Health, Inc. for the device "Cala ONE". The FDA issued a decision of De Novo Granted on Apr 26, 2018. The device falls under product code QBC (External Upper Limb Tremor Stimulator), a Class II device regulated under 21 CFR 882.5897. Cala Health, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 26, 2018
- Date Received
- May 17, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Upper Limb Tremor Stimulator
- Device Class
- Class II
- Regulation Number
- 882.5897
- Review Panel
- NE
- Submission Type
An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.