510(k) K821836
K821836 is an FDA 510(k) premarket notification submitted by Body Therapeutics, Inc. for the device "PREGNANCY (W) EDGE". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code QSB (Orthosis, Truncal, Pregnancy), a Class I device regulated under 21 CFR 890.3490. Body Therapeutics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1982
- Date Received
- June 22, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Truncal, Pregnancy
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- OB
- Submission Type
Provide abdominal and back support during pregnancy