FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
M-BRACE
K Number: K823882
·
Decision Jan 17, 1983
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
10
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- M-BRACE
- K Number
- K823882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Buckman Consultants
- Date Received
- December 27, 1982
- Decision Date
- January 17, 1983
- Product Code
- IPY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | FDA class 1 | Physical Medicine |
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