Tyece OTC EMS System, Model EM35
FDA 510(k) clearance K172241 · decided 2017-11-20
Clearance details
- K-number
- K172241
- Device name
- Tyece OTC EMS System, Model EM35
- Applicant
- Tyece , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-26
- Decision date
- 2017-11-20
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- NGX
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Kowloon, HK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.