THE HANDSCAN SYSTEM
FDA 510(k) clearance K893455 · decided 1989-08-30
Clearance details
- K-number
- K893455
- Device name
- THE HANDSCAN SYSTEM
- Applicant
- Digital Body Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-03
- Decision date
- 1989-08-30
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- KQX
- Device class
- 1
- Regulation number
- 888.1500
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| LARGE MUSCLE STRENGTH GAUGE (K945630) | J-Tech, Inc. | 1995-05-10 |
| SAUNDERS ELECTRONIC INCLINOMETER (K943898) | The Saunders Group | 1994-11-28 |
| INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812) | Andronic Devices, Ltd. | 1994-11-21 |
| THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (K925225) | Baltimore Therapeutic Equipment Co. | 1994-06-27 |
| ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (K933063) | Isotechnologies, Inc. | 1994-01-27 |
| BOOST, MICE, GAMESYS. (K924416) | Penny and Giles Biometrics , Ltd. | 1993-06-15 |
Recalls involving this device
No recalls on record reference this clearance.