| Device Classification Name |
Massager, Powered Inflatable Tube
|
|---|
| 510(k) Number |
K254200 |
|---|
| Device Name |
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) |
|---|
| Applicant |
| Wenzhou Lingfeng Electronic Technology Co., Ltd. |
| #6 Puxi Industry Zone, Tongpu |
|
Ruian,
CN
325216
|
|
| Applicant Contact |
Xiaoqun Ye |
| Correspondent |
| Shenzhen Reanny Medical Devices Management Consulting Co.,Lt |
| Rm. 1509, Jingting Bldg., Dongzhou Community, Guangming St., |
|
Shenzhen,
CN
518107
|
|
| Correspondent Contact |
Reanny Wang |
| Regulation Number | 890.5650 |
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 12/29/2025 |
|---|
| Decision Date | 05/05/2026 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Physical Medicine
|
|---|
| 510k Review Panel |
Physical Medicine
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
