510(k) K802442
K802442 is an FDA 510(k) premarket notification submitted by Body Therapeutics, Inc. for the device "LOW BACK POSTURE PILLOW". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code IQK (Orthosis, Cervical), 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
- October 31, 1980
- Date Received
- October 7, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cervical
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type