510(k) K832968
K832968 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "PEDAL EXERCISER". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Maddak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1983
- Date Received
- September 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type