510(k) K051197
K051197 is an FDA 510(k) premarket notification submitted by Inno-Health Technology, Inc. for the device "ACULIFE, MODEL SMW-01". The FDA issued a decision of Substantially Equivalent on March 28, 2006. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. Inno-Health Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2006
- Date Received
- May 10, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electro-Acupuncture
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type