510(k) K934886
K934886 is an FDA 510(k) premarket notification submitted by Next Wave, Inc. for the device "NEXT WAVE PHYSIOACOUSTIC MATTRESS". The FDA issued a decision of SN on June 9, 1994. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Next Wave, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- June 9, 1994
- Date Received
- October 12, 1993
- 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