510(k) K821619
K821619 is an FDA 510(k) premarket notification submitted by Therapeutic Recreation Systems, Inc. for the device "THE SPORTS HAND". The FDA issued a decision of Substantially Equivalent on July 20, 1982. The device falls under product code IRA (Hand, External Limb Component, Mechanical), a Class I device regulated under 21 CFR 890.3420. Therapeutic Recreation Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1982
- Date Received
- June 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hand, External Limb Component, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type