RELIANT CHARGER
FDA 510(k) clearance K971768 · decided 1997-09-29
Clearance details
- K-number
- K971768
- Device name
- RELIANT CHARGER
- Applicant
- Walling Medical Equipment Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-13
- Decision date
- 1997-09-29
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- LKY
- Device class
- 2
- Regulation number
- 876.5020
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mckinney, TX, 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 |
|---|---|---|
| NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (K041573) | Nanma Mfg Co., Ltd. | 2004-08-25 |
| VACURECT VACUUM CONSTRICTION DEVICE (K032776) | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 |
| NANMA ADJUSTABLE CONSTRICTION RING (K030119) | Nanma Mfg Co., Ltd. | 2003-08-06 |
| NANMA VACUUM PUMP (K030913) | Nanma Mfg Co., Ltd. | 2003-06-03 |
| MODIFICATION TO NANMA VACUUM PUMP (K013113) | Nanma Mfg Co., Ltd. | 2002-12-20 |
| NANMA ADJUSTABLE CONSTRICTION RING (K013051) | Nanma Mfg Co., Ltd. | 2002-08-22 |
| VACURECT VACUUM CONSTRICTION DEVICE (K020969) | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 |
| MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (K013053) | Nanma Mfg Co., Ltd. | 2002-05-09 |
| VT-1 (K020154) | Pos-T-Vac, Inc. | 2002-04-04 |
| SUPPORT SLEEVE (K020258) | Pos-T-Vac, Inc. | 2002-04-04 |
| ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM (K020082) | Endocare, Inc. | 2002-02-05 |
| SE-100 VACUUM ERECTION DEVICE (K012662) | Vts, Inc. | 2001-11-09 |
Recalls involving this device
No recalls on record reference this clearance.