DISCIPLINE I
FDA 510(k) clearance K870872 · decided 1987-03-23
Clearance details
- K-number
- K870872
- Device name
- DISCIPLINE I
- Applicant
- Physio Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-03
- Decision date
- 1987-03-23
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- ISD
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| ERGOSELECT/GE (K112121) | Ergoline GmbH | 2012-10-31 |
| ACTITRAINER (K080545) | Actigraph, LLC | 2008-07-24 |
| ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (K053078) | Ergoline GmbH | 2006-04-27 |
| QUINTON MEDTRACK CR PLUS TREADMILL (K990866) | Quinton, Inc. | 1999-04-29 |
| REHCOR (K990813) | Electromed Corp. | 1999-04-12 |
| ULE-2, MULE-2, HAND ACCESSORY KIT (K962855) | Penny and Giles Biometrics , Ltd. | 1996-12-11 |
| DAVID BACK CLINIC SYSTEM (K952163) | Kinetic Resources, Inc. | 1996-08-12 |
| PHYSIO HAB (K941033) | Longo Industries | 1995-02-27 |
| SES100 (K940065) | Southwest Ergonomics | 1994-12-06 |
Recalls involving this device
No recalls on record reference this clearance.