SINGLE CHAIR INTEGRAL BACK ATTACHMENT
FDA 510(k) clearance K922092 · decided 1992-05-26
Clearance details
- K-number
- K922092
- Device name
- SINGLE CHAIR INTEGRAL BACK ATTACHMENT
- Applicant
- Biodan Medical Systems, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-05
- Decision date
- 1992-05-26
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IKK
- Device class
- 2
- Regulation number
- 890.1925
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Shirley, NY, US
- Third-party review
- No
- Expedited review
- No
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| MOTIVATOR FTR 2000 (K942229) | Hogan & Hartson | 1995-02-27 |
| DEXTER ISOKINETIC (K944732) | Cedaron Medical, Inc. | 1995-02-03 |
| THE BTE DYNAMIC LIFT (K924414) | Baltimore Therapeutic Equipment Co. | 1993-02-12 |
| CLOSED CHAIN ATTACHMENT, MODEL #820-520 (K923350) | Biodan Medical Systems, Ltd. | 1992-07-23 |
| TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (K922772) | Biodan Medical Systems, Ltd. | 1992-07-13 |
| DEXTER HAND EVALUATION AND THERAPY SYSTEM (K915144) | Cedars Medical Center | 1992-04-02 |
| BIODEX SYSTEM 2 AUTOPROGRAM (K915846) | Biodex Corp. | 1992-01-13 |
Recalls involving this device
No recalls on record reference this clearance.