The following data is part of a premarket notification filed by Stl International, Inc. with the FDA for Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table.
Device ID | K162702 |
510k Number | K162702 |
Device Name: | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table |
Classification | Apparatus, Traction, Non-powered |
Applicant | STL International, Inc. 9902 162nd Street, Court E Puyallup, WA 98375 |
Contact | Rylie Teeter Leier |
Correspondent | Korina A. Akhondzadeh KARA & Associates 6965 El Camino Real Suite 105-428 Carlsbad, CA 92009 |
Product Code | HST |
CFR Regulation Number | 888.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-28 |
Decision Date | 2016-12-30 |
Summary: | summary |