510(k) K002908
K002908 is an FDA 510(k) premarket notification submitted by Jet Therapy for the device "JET THERAPY". The FDA issued a decision of Substantially Equivalent on August 30, 2001. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2001
- Date Received
- September 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Electric
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type