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Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table

K162702 Class I Traditional
Decision Date
2016-12-30
Sponsor / Applicant
Stl International, Inc.

Technical Specification

510(k) Submission ID K162702
Product Code HST
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.5850
Decision Date 2016-12-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table received FDA 510(k) clearance under submission number K162702, sponsored by Stl International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-12-30.

Classification & Regulation

This clearance is catalogued under FDA product code HST and 21 CFR 888.5850, within the Orthopedic review panel as a Class I device.