TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
FDA 510(k) clearance K050428 · decided 2005-06-14
Clearance details
- K-number
- K050428
- Device name
- TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
- Applicant
- Advanced Spinal Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-18
- Decision date
- 2005-06-14
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- LXM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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| VSTAAR AdjusteR (K160278) | Spinal Acoustics, LLC | 2016-11-04 |
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| ACTIVATOR V-E (K112606) | Activator Methods International, Ltd. | 2012-03-06 |
| MAX ADJUSTING INSTRUMENT (K082218) | Manna Omni International, Inc. | 2008-08-13 |
| IMPULSE IQ ADJUSTING INSTRUMENT (K080261) | Neuromechanical Innovations, LLC | 2008-04-11 |
| ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (K072519) | Activator Methods International, Ltd. | 2007-10-23 |
| KHAN KINETIC TREATMENT DEVICE (KKT-M1) (K060043) | Optima Health Solutions International, Inc. | 2006-03-23 |
| IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003 (K023462) | Neuromechanical Innovations, LLC | 2003-01-13 |
| FRYE ADJUSTING INSTRUMENT (K021238) | Frye Health Systems | 2002-10-09 |
Recalls involving this device
No recalls on record reference this clearance.