Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
FDA 510(k) clearance K162702 · decided 2016-12-30
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-28
- Decision date
- 2016-12-30
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- HST
- Device class
- 1
- Regulation number
- 888.5850
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Puyallup, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LO-BAK TRAX (K110858) | Roland F Berthiaume, DC | 2011-08-02 |
| BACK-ON-TRAC, MODEL 101BOT (K984190) | Back-On-Track, Inc. | 1999-03-15 |
| K AND D HOME TRACT (K872121) | Joseph A. Kott, M.D. | 1987-08-12 |
| ARTHROSCOPIC SHOULDER HOLDER (K870212) | Dyonics, Inc. | 1987-02-20 |
| EXTREMITY ELEVATOR (K870125) | Orthopedic Systems, Inc. | 1987-02-04 |
| TUPPER TROLLEY (K870102) | Orthopedic Systems, Inc. | 1987-02-03 |
| MODEL 668, TRACTION SPLINT, ADULT (K864765) | Ferno-Washington, Inc. | 1986-12-17 |
| THE TOWERED 90/90 UNIT (K862874) | Lossing Orthopedic, Inc. | 1986-08-07 |
| TRANSFER-TRAX (TM) SPLINT TRACTION (K855179) | Comfortex, Inc. | 1986-01-21 |
| SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (K860037) | Comfortex, Inc. | 1986-01-21 |
| NEC-KRADLE BY VENCOR (K844239) | Vencor | 1984-11-19 |
| HYPERBARIC OXYGEN GURNEY- (K841368) | Orthopedic Systems, Inc. | 1984-05-16 |
Recalls involving this device
No recalls on record reference this clearance.