The following data is part of a premarket notification filed by Cala Health, Inc. with the FDA for External Upper Limb Tremor Stimulator.
| Device ID | K182706 |
| 510k Number | K182706 |
| Device Name: | External Upper Limb Tremor Stimulator |
| Classification | External Upper Limb Tremor Stimulator |
| Applicant | Cala Health, Inc. 875 Mahler Road, Suite 168 Burlingame, CA 94010 |
| Contact | Scott A. Wilson |
| Correspondent | Scott A. Wilson Cala Health, Inc. 875 Mahler Road, Suite 168 Burlingame, CA 94010 |
| Product Code | QBC |
| CFR Regulation Number | 882.5897 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-10-25 |