510(k) K931636
K931636 is an FDA 510(k) premarket notification submitted by Fairform Mfg., Co., Ltd. for the device "FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Fairform Mfg., Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1994
- Date Received
- March 31, 1993
- 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