BIODEX SYSTEM
FDA 510(k) clearance K860821 · decided 1986-04-18
Clearance details
- K-number
- K860821
- Device name
- BIODEX SYSTEM
- Applicant
- Biodex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-04
- Decision date
- 1986-04-18
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- IKK
- Device class
- 2
- Regulation number
- 890.1925
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Center Moriches, NY, 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 |
|---|---|---|
| AMES THERAPY DEVICE (K123746) | Ames Technology, Inc. | 2013-05-24 |
| HUMAC SYSTEM (K952090) | Computer Sports Medicine, Inc. | 1995-12-11 |
| BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (K951770) | Biodex Medical Systems, Inc. | 1995-11-16 |
| CC RIDER, MODEL ME180 (K951916) | Mettler Electronics Corp. | 1995-10-04 |
| CYBEX 770 (K950095) | Cybex | 1995-06-21 |
| 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 |
| SINGLE CHAIR INTEGRAL BACK ATTACHMENT (K922092) | Biodan Medical Systems, Ltd. | 1992-05-26 |
| DEXTER HAND EVALUATION AND THERAPY SYSTEM (K915144) | Cedars Medical Center | 1992-04-02 |
Recalls involving this device
No recalls on record reference this clearance.