FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERADAPT HIGHCHAIR/STROLLER INSERT
K Number: K942397
·
Decision Jun 22, 1994
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
25
Applicant Total
5
Review Days
34
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Basic Information
- Device Name
- THERADAPT HIGHCHAIR/STROLLER INSERT
- K Number
- K942397
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Theradapt Products, Inc.
- Date Received
- May 19, 1994
- Decision Date
- June 22, 1994
- Product Code
- INN
- 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 |
|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | FDA class 1 | Physical Medicine |
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