Transcutaneous Electrical Nerve Stimulators (TENS)
FDA 510(k) clearance K150043 · decided 2015-08-14
Clearance details
- K-number
- K150043
- Device name
- Transcutaneous Electrical Nerve Stimulators (TENS)
- Applicant
- Andon Health Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-09
- Decision date
- 2015-08-14
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Andon Health Co
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.