G-TRAINER MEDICAL
FDA 510(k) clearance K072887 · decided 2008-01-25
Clearance details
- K-number
- K072887
- Device name
- G-TRAINER MEDICAL
- Applicant
- Alter-G, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-10
- Decision date
- 2008-01-25
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- BXB
- Device class
- 1
- Regulation number
- 890.5380
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| FLO-BOOT (K003272) | Discovery Group, LLC | 2001-04-04 |
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| HAMEX TWO (K951028) | Northern Orthopaedic Products, Inc. | 1995-12-11 |
| FLEXMATE K500 (K950755) | Breg, Inc. | 1995-10-05 |
| HAMEX ONE (K951029) | Northern Orthopaedic Products, Inc. | 1995-09-15 |
| AQUAHAB, MODEL 120-72-101 (K945733) | Aquarius Electronics, Inc. | 1995-09-15 |
| W2 WRIST CPM UNIT (K950682) | Toronto Medical Corp. | 1995-09-13 |
| KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (K952369) | Physicians Consulting, Inc. | 1995-08-07 |
| BACKCYCLER CPM(TM) (K945690) | Ergomedics, Inc. | 1995-06-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usa recall (Z-3026-2011) | Alter-G, Incorporated | 2011-08-16 |