Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
FDA 510(k) clearance K191982 · decided 2020-09-25
Clearance details
- K-number
- K191982
- Device name
- Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
- Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-25
- Decision date
- 2020-09-25
- Days to decision
- 428 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.