510(k) K031621
K031621 is an FDA 510(k) premarket notification submitted by Comfort Orthopedic Co., Ltd. for the device "HERO 1, MODEL LY-ESB220". The FDA issued a decision of Substantially Equivalent on January 22, 2004. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Comfort Orthopedic Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2004
- Date Received
- May 23, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type