510(k) K912822
K912822 is an FDA 510(k) premarket notification submitted by Raymond Industrial, Ltd. for the device "PERSONAL BODY MASSAGER, MODELS 1605 & 1606". The FDA issued a decision of Substantially Equivalent on February 11, 1992. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Raymond Industrial, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1992
- Date Received
- June 25, 1991
- 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