TMJ Relax
FDA 510(k) clearance K202523 · decided 2021-06-24
Clearance details
- K-number
- K202523
- Device name
- TMJ Relax
- Applicant
- Moonwalker Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-01
- Decision date
- 2021-06-24
- Days to decision
- 296 days
- Clearance type
- Traditional
- Product code
- OCO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Medford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| The Luco Hybrid OSA Appliance (K160477) | Luco Hybrid Osa Appliance, Inc. | 2016-07-29 |
| NTI TENSION SUPPRESSION SYSTEM (K010876) | Nti-Tss, Inc. | 2001-06-20 |
Recalls involving this device
No recalls on record reference this clearance.