Device Classification Name |
apparatus, traction, non-powered
|
510(k) Number |
K162702 |
Device Name |
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table |
Applicant |
STL International, Inc. |
9902 162nd Street, Court E |
Puyallup,
WA
98375
|
|
Applicant Contact |
Rylie Teeter Leier |
Correspondent |
KARA & Associates |
6965 El Camino Real |
Suite 105-428 |
Carlsbad,
CA
92009
|
|
Correspondent Contact |
Korina A. Akhondzadeh |
Regulation Number | 888.5850
|
Classification Product Code |
|
Date Received | 09/28/2016 |
Decision Date | 12/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|