FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAND THERAPY ASSOST
K Number: K933418
·
Decision Apr 28, 1994
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
11
Applicant Total
1
Review Days
289
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Basic Information
- Device Name
- HAND THERAPY ASSOST
- K Number
- K933418
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5410
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bardon Ent., Inc.
- Date Received
- July 13, 1993
- Decision Date
- April 28, 1994
- Product Code
- JFA
- 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 |
|---|---|---|---|
| JFA | Exerciser, Finger, Powered | FDA class 1 | Physical Medicine |
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