FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREGNANCY (W) EDGE
K Number: K821836
·
Decision Jul 30, 1982
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
5
Review Days
38
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Basic Information
- Device Name
- PREGNANCY (W) EDGE
- K Number
- K821836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Body Therapeutics, Inc.
- Date Received
- June 22, 1982
- Decision Date
- July 30, 1982
- Product Code
- QSB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QSB | Orthosis, Truncal, Pregnancy | FDA class 1 | Physical Medicine |
Other Clearances by Body Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Jun 15, 1983 | Substantially Equivalent |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | Jul 20, 1982 | Substantially Equivalent |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Jul 20, 1982 | Substantially Equivalent |
| K802442 | LOW BACK POSTURE PILLOW | Oct 31, 1980 | Substantially Equivalent |