Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
FDA 510(k) clearance K170205 · decided 2017-05-11
Clearance details
- K-number
- K170205
- Device name
- Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
- Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-23
- Decision date
- 2017-05-11
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.