FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
K Number: K162702
·
Decision Dec 30, 2016
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
1
Review Days
93
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Basic Information
- Device Name
- Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
- K Number
- K162702
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stl International, Inc.
- Date Received
- September 28, 2016
- Decision Date
- December 30, 2016
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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