iRelieve Microcurrent Pain Relief System
FDA 510(k) clearance K212618 · decided 2022-09-14
Clearance details
- K-number
- K212618
- Device name
- iRelieve Microcurrent Pain Relief System
- Applicant
- Fast Track Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-18
- Decision date
- 2022-09-14
- Days to decision
- 392 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.