510(k) K770146
K770146 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "SWIVEL HEAD ADJUSTABLE CRUTCH". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code IPR (Crutch), a Class I device regulated under 21 CFR 890.3150. Maddak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1977
- Date Received
- January 24, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crutch
- Device Class
- Class I
- Regulation Number
- 890.3150
- Review Panel
- PM
- Submission Type