510(k) K971542
- Device
- ORTHO DX NEUROMUSCULAR STIMULATOR
- Applicant
- REHABILICARE, INC.
- 510(k) number
- K971542
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-14
- Date received
- 1997-04-28
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY L MOORE
- Address
- 1811 Old Hwy. 8 New Brighton MN US 55112 55112
FDA Registration Numbers#
- 3013602304
- 3043657394
- 3033530347
- 3013927823
- 3027669735
- 3025235024
- 8022189
- 3011410128
- 9710580
- 3012168464
- 3013917867
- 3030956509
- 3003895865
- 3023613474
- 3017936974
- 3016512343
- 3011267903
- 2026803
- 1930027
- 3020683829
- 1063324
- 3004733458
- 9616086
- 3011191255
- 1055808
- 9710582
- 2954348
- 3001676837
- 3012251759
- 1061158
- 3017450375
- 3004183512
- 3004146401
- 1644243
- 3010805941
- 9613347
- 2023152
- 3013671142
- 2024292
- 3010402752
- 3005569927
- 3004049909
- 3011466827
- 1911273
- 3008525454
- 3011767724
- 9613462
- 3038138457
- 3004413879
- 3043011436
- 3037609256
- 3013069546
- 3023339107
- 3042228064
- 3013375723
- 3001431138
- 9680487
- 2031823
- 3003631667
- 3008008477
- 3043012240
- 3010385841
- 3008770252
- 3015588280
- 3033847811
- 3045753434
- 3017866822
- 3035374386
- 8010720
- 3013401749
- 9617486
- 3016670292
- 3006551156
- 3043012074
- 3010511300
- 3032062344
- 3043153468
- 8040537
- 9612147
Source Documents#
Other 510(k) Records For Product Code IPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
Legacy Summary#
summary
FDA Review#
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