Transcutaneous Electrical Nerve Stimulator
FDA 510(k) clearance K202893 · decided 2021-06-18
Clearance details
- K-number
- K202893
- Device name
- Transcutaneous Electrical Nerve Stimulator
- Applicant
- Wuxi Jiajian Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-28
- Decision date
- 2021-06-18
- Days to decision
- 263 days
- Clearance type
- Special
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Wuxi, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.