GRAVITY KING (DEEMED SE 87/09/18)
FDA 510(k) clearance K851065 · decided 1985-06-13
Clearance details
- K-number
- K851065
- Device name
- GRAVITY KING (DEEMED SE 87/09/18)
- Applicant
- Unique Functional Products
- Decision
- Substantially Equivalent
- Date received
- 1985-03-15
- Decision date
- 1985-06-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- ION
- Device class
- 1
- Regulation number
- 890.5370
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Marcos, CA, 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 |
|---|---|---|
| ABLE-X (K120783) | Im-Able, Ltd. | 2012-06-20 |
| STANDEX (K885343) | Alt, Inc. | 1989-05-01 |
| MOBILIZER (K840551) | Lossing Orthopedic, Inc. | 1984-03-23 |
| KNEE WALKER (K833870) | Maddak, Inc. | 1983-11-29 |
| FITNESS (K833249) | Fitness Equipment Co., Inc. | 1983-11-07 |
| PEDAL EXERCISER (K832968) | Maddak, Inc. | 1983-09-29 |
| ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (K831543) | Fred Sammons, Inc. | 1983-06-24 |
| DELUXE ADJUST-ANGLE BOARD-BK4066 (K831538) | Fred Sammons, Inc. | 1983-06-08 |
| GIREX (K831033) | Lancer Assoc. | 1983-04-27 |
| MADDATRAINER HAND EXERCISER (K830400) | Maddak, Inc. | 1983-03-09 |
| EXERCISER, PASSIVE, NON MEASURING (K830560) | Kaye Products, Inc. | 1983-03-09 |
| BACK ON TRACK INVERSION THERAPY & EXER (K823236) | Lossing Orthopedic, Inc. | 1983-01-21 |
Recalls involving this device
No recalls on record reference this clearance.