Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
FDA 510(k) clearance K202470 · decided 2020-11-25
Clearance details
- K-number
- K202470
- Device name
- Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
- Applicant
- Everyway Medical Instruments Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2020-08-28
- Decision date
- 2020-11-25
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenkeng District, New Taipei City, CN
- 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.
Recalls involving this device
No recalls on record reference this clearance.