510(k) K955250
K955250 is an FDA 510(k) premarket notification submitted by East Health Development Group, Inc. for the device "QI GONG MASSAGER". The FDA issued a decision of SN on February 8, 1996. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 8, 1996
- Date Received
- November 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type