HOOKING SYSTEM
FDA 510(k) clearance K930613 · decided 1994-07-12
Clearance details
- K-number
- K930613
- Device name
- HOOKING SYSTEM
- Applicant
- Alain Machtelinckx
- Decision
- Substantially Equivalent
- Date received
- 1993-02-05
- Decision date
- 1994-07-12
- Days to decision
- 522 days
- Clearance type
- Traditional
- Product code
- LYG
- Device class
- 1
- Regulation number
- 890.5660
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- West Linn, OR, 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 |
|---|---|---|
| MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (K963704) | Shippert Medical Technologies Corp. | 1996-11-26 |
| MANUAL MASSAGE ROLLER (K936312) | Mckenna & Cuneo | 1996-01-29 |
| BACK MASSAGER (K952043) | Eight Corners, Inc. | 1995-09-01 |
| STRESS HANDLER (K936148) | Arocep Enterprises , Ltd. | 1994-04-21 |
| THE MASSAGER (K924315) | Four Directions | 1993-10-08 |
| SPINE LINE (K922366) | Dambrecine, Inc. | 1992-07-13 |
| THE BODY BUGGY (K915361) | Innova Corp. | 1991-12-20 |
| TAICHI STICK MASSAGER (K912512) | Focus International, Inc. | 1991-09-06 |
| THERA-CANE (K903820) | Pro Message Co. | 1990-09-19 |
| BUMPY MEDICAL MASSAGE MAT (K884907) | Medical Flotation Systems, Inc. | 1988-12-27 |
| DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER (K881081) | Ferguson Medical | 1988-07-21 |
| DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER (K881080) | Ferguson Medical | 1988-07-21 |
Recalls involving this device
No recalls on record reference this clearance.